Re: NYTimes/Osteoporosis cure?

[Guest guest]

I saw this on the news last night. At first glance it seems very

promising, but on reading this AP write up I wonder if the risk of bone

cancer with thyca patients might prevent our use of the drug. Hopefully

not!

>However, researchers eventually decided that the results do not

>suggest a higher cancer risk in people. Among other things, people

>with naturally high levels of the hormone as a result of overactive

>parathyroid glands are not especially prone to bone cancer, and none

>of the women in this or earlier studies of the hormone has developed >>the

cancer.

Gail

dx1968,TT,pap. & foll. well differentiated, RAI, rad.neck

dissection, lung surgery, hashimoto, iodine resistant,

existing thyca nodules in lungs. Last surgery 1972

> From the New York Times, about an article in today's New

> England Journal of Medicine:

>

> May 9, 2001

>

> Natural Hormone Helps Osteoporosis

>

> By THE ASSOCIATED PRESS

>

> BOSTON (AP) -- A natural bone-building hormone appears to be

> the most effective treatment ever for osteoporosis, the brittle

> bone disease that afflicts millions of older Americans.

>

> The manufacturer hopes the medicine, called Forteo

> (for-TAY-oh), will be available by prescription by the end of the

> year. If so, it is likely to be recommended for victims of moderate

> to severe osteoporosis, a condition blamed for more than 1.5

> million fractures annually in the United States.

>

> The drug is based on the parathyroid hormone, which is

> ordinarily secreted by tiny glands in the neck. When given to

> volunteers with osteoporosis, it doubles their normal rate of

> bone formation.

>

> A study in Thursday's New England Journal of Medicine shows

> that it dramatically reduces the risk of broken bones. The risk of

> spinal fractures, a hallmark of osteoporosis, fell by two-thirds in

> women getting the medicine.

>

> Other osteoporosis drugs on the market, such as Fosamax,

> work by slowing the body's loss of bone. Forteo is the only

> treatment that actually prompts the body to make new bone.

>

> But unlike the other medicines, Forteo has a major drawback: It

> can be administered only by daily injections. Still, doctors say

> patients quickly master this process, which is similar to insulin

> injections, and no serious side effects were seen.

>

> ``It's the first demonstration of the concept that stimulating bone

> formation is going to be an effective way to treat osteoporosis in

> humans,'' said Dr. M. Neer of Massachusetts General

> Hospital, the study's director.

>

> The medicine, known generically as teriparatide, is being

> developed by Eli Lilly, which financed the study.

>

> Dr. Felicia Cosman of Helen Hospital in West

> Haverstraw, N.Y., clinical director of the National Osteoporosis

> Foundation, estimated that 25 percent to 30 percent of

> osteoporosis patients might be considered for treatment with the

> new drug.

>

> ``It represents a lot of hope for the future for women with severe

> osteoporosis, especially those who are on the best drugs and

> still having fractures,'' she said.

>

> The foundation estimates that 10 million Americans -- 80

> percent of them female -- have osteoporosis. Broken vertebrae,

> hips and wrists are especially common.

>

> The latest study was conducted on 1,637 postmenopausal

> women who had suffered at least one fracture because of

> osteoporosis. They were randomly assigned to take either 20 or

> 40 micrograms of the hormone or dummy shots. After 18

> months of treatment, women taking the higher dose of drug had

> 13 percent more bone in their spines than did those on the

> placebo.

>

> Forteo has not been compared directly to other drugs, so doctors

> cannot say for sure that it is truly better. However, the results of

> this and other studies with the new medicine are more

> impressive than those typically seen with other drugs. For

> instance, the researchers said the largest increase in bone

> seen with other drugs was 9 percent.

>

> Forteo reduced the occurrence of new vertebral fractures by 65

> percent or 69 percent, depending on whether women got the

> high or low dose. Neer said no other drug has reduced it by

> more than 40 percent to 50 percent.

>

> The new drug reduced the risk of multiple spinal fractures by 77

> percent or 86 percent, and it lowered the risk of fractures

> elsewhere in the body by just over half.

>

> The study was stopped early because of a cancer scare

> resulting from other Lilly research in which scientists found that

> rats developed bone cancer when given high lifelong doses of

> the drug.

>

> However, researchers eventually decided that the results do not

> suggest a higher cancer risk in people. Among other things,

> people with naturally high levels of the hormone as a result of

> overactive parathyroid glands are not especially prone to bone

> cancer, and none of the women in this or earlier studies of the

> hormone has developed the cancer.

>

> The entire parathyroid hormone contains 84 amino acids. Forteo

> is a 34-amino acid portion of this. Experts believe it does the

> same job as the full hormone.

> ^------

[Guest guest]

I saw this on the news last night. At first glance it seems very

promising, but on reading this AP write up I wonder if the risk of bone

cancer with thyca patients might prevent our use of the drug. Hopefully

not!

>However, researchers eventually decided that the results do not

>suggest a higher cancer risk in people. Among other things, people

>with naturally high levels of the hormone as a result of overactive

>parathyroid glands are not especially prone to bone cancer, and none

>of the women in this or earlier studies of the hormone has developed >>the

cancer.

Gail

dx1968,TT,pap. & foll. well differentiated, RAI, rad.neck

dissection, lung surgery, hashimoto, iodine resistant,

existing thyca nodules in lungs. Last surgery 1972

> From the New York Times, about an article in today's New

> England Journal of Medicine:

>

> May 9, 2001

>

> Natural Hormone Helps Osteoporosis

>

> By THE ASSOCIATED PRESS

>

> BOSTON (AP) -- A natural bone-building hormone appears to be

> the most effective treatment ever for osteoporosis, the brittle

> bone disease that afflicts millions of older Americans.

>

> The manufacturer hopes the medicine, called Forteo

> (for-TAY-oh), will be available by prescription by the end of the

> year. If so, it is likely to be recommended for victims of moderate

> to severe osteoporosis, a condition blamed for more than 1.5

> million fractures annually in the United States.

>

> The drug is based on the parathyroid hormone, which is

> ordinarily secreted by tiny glands in the neck. When given to

> volunteers with osteoporosis, it doubles their normal rate of

> bone formation.

>

> A study in Thursday's New England Journal of Medicine shows

> that it dramatically reduces the risk of broken bones. The risk of

> spinal fractures, a hallmark of osteoporosis, fell by two-thirds in

> women getting the medicine.

>

> Other osteoporosis drugs on the market, such as Fosamax,

> work by slowing the body's loss of bone. Forteo is the only

> treatment that actually prompts the body to make new bone.

>

> But unlike the other medicines, Forteo has a major drawback: It

> can be administered only by daily injections. Still, doctors say

> patients quickly master this process, which is similar to insulin

> injections, and no serious side effects were seen.

>

> ``It's the first demonstration of the concept that stimulating bone

> formation is going to be an effective way to treat osteoporosis in

> humans,'' said Dr. M. Neer of Massachusetts General

> Hospital, the study's director.

>

> The medicine, known generically as teriparatide, is being

> developed by Eli Lilly, which financed the study.

>

> Dr. Felicia Cosman of Helen Hospital in West

> Haverstraw, N.Y., clinical director of the National Osteoporosis

> Foundation, estimated that 25 percent to 30 percent of

> osteoporosis patients might be considered for treatment with the

> new drug.

>

> ``It represents a lot of hope for the future for women with severe

> osteoporosis, especially those who are on the best drugs and

> still having fractures,'' she said.

>

> The foundation estimates that 10 million Americans -- 80

> percent of them female -- have osteoporosis. Broken vertebrae,

> hips and wrists are especially common.

>

> The latest study was conducted on 1,637 postmenopausal

> women who had suffered at least one fracture because of

> osteoporosis. They were randomly assigned to take either 20 or

> 40 micrograms of the hormone or dummy shots. After 18

> months of treatment, women taking the higher dose of drug had

> 13 percent more bone in their spines than did those on the

> placebo.

>

> Forteo has not been compared directly to other drugs, so doctors

> cannot say for sure that it is truly better. However, the results of

> this and other studies with the new medicine are more

> impressive than those typically seen with other drugs. For

> instance, the researchers said the largest increase in bone

> seen with other drugs was 9 percent.

>

> Forteo reduced the occurrence of new vertebral fractures by 65

> percent or 69 percent, depending on whether women got the

> high or low dose. Neer said no other drug has reduced it by

> more than 40 percent to 50 percent.

>

> The new drug reduced the risk of multiple spinal fractures by 77

> percent or 86 percent, and it lowered the risk of fractures

> elsewhere in the body by just over half.

>

> The study was stopped early because of a cancer scare

> resulting from other Lilly research in which scientists found that

> rats developed bone cancer when given high lifelong doses of

> the drug.

>

> However, researchers eventually decided that the results do not

> suggest a higher cancer risk in people. Among other things,

> people with naturally high levels of the hormone as a result of

> overactive parathyroid glands are not especially prone to bone

> cancer, and none of the women in this or earlier studies of the

> hormone has developed the cancer.

>

> The entire parathyroid hormone contains 84 amino acids. Forteo

> is a 34-amino acid portion of this. Experts believe it does the

> same job as the full hormone.

> ^------

[Guest guest]

Re: the last sentence of Gail's post. I was one of the women in the " earlier

studies " of hPTH (1-34) for use in hypoparathyroidism. It has not been long

enough to know if we will get bone cancer in the future.

From the New York Times, about an article in today's New

England Journal of Medicine:

May 9, 2001

Natural Hormone Helps Osteoporosis

By THE ASSOCIATED PRESS

BOSTON (AP) -- A natural bone-building hormone appears to be the most effective

treatment ever for osteoporosis, the brittle bone disease that afflicts millions

of older Americans.

The manufacturer hopes the medicine, called Forteo (for-TAY-oh), will be

available by prescription by the end of the year. If so, it is likely to be

recommended for victims of moderate to severe osteoporosis, a condition blamed

for more than 1.5 million fractures annually in the United States.

The drug is based on the parathyroid hormone, which is ordinarily secreted by

tiny glands in the neck. When given to volunteers with osteoporosis, it doubles

their normal rate of bone formation.

A study in Thursday's New England Journal of Medicine shows that it dramatically

reduces the risk of broken bones. The risk of spinal fractures, a hallmark of

osteoporosis, fell by two-thirds in women getting the medicine.

Other osteoporosis drugs on the market, such as Fosamax, work by slowing the

body's loss of bone. Forteo is the only treatment that actually prompts the body

to make new bone.

But unlike the other medicines, Forteo has a major drawback: It can be

administered only by daily injections. Still, doctors say patients quickly

master this process, which is similar to insulin injections, and no serious side

effects were seen.

``It's the first demonstration of the concept that stimulating bone formation is

going to be an effective way to treat osteoporosis in humans,'' said Dr.

M. Neer of Massachusetts General Hospital, the study's director.

The medicine, known generically as teriparatide, is being developed by Eli

Lilly, which financed the study.

Dr. Felicia Cosman of Helen Hospital in West Haverstraw, N.Y., clinical

director of the National Osteoporosis Foundation, estimated that 25 percent to

30 percent of osteoporosis patients might be considered for treatment with the

new drug.

``It represents a lot of hope for the future for women with severe osteoporosis,

especially those who are on the best drugs and still having fractures,'' she

said.

The foundation estimates that 10 million Americans -- 80 percent of them female

-- have osteoporosis. Broken vertebrae, hips and wrists are especially common.

The latest study was conducted on 1,637 postmenopausal women who had suffered at

least one fracture because of osteoporosis. They were randomly assigned to take

either 20 or 40 micrograms of the hormone or dummy shots. After 18 months of

treatment, women taking the higher dose of drug had 13 percent more bone in

their spines than did those on the placebo.

Forteo has not been compared directly to other drugs, so doctors cannot say for

sure that it is truly better. However, the results of this and other studies

with the new medicine are more impressive than those typically seen with other

drugs. For instance, the researchers said the largest increase in bone seen with

other drugs was 9 percent.

Forteo reduced the occurrence of new vertebral fractures by 65 percent or 69

percent, depending on whether women got the high or low dose. Neer said no other

drug has reduced it by more than 40 percent to 50 percent.

The new drug reduced the risk of multiple spinal fractures by 77 percent or 86

percent, and it lowered the risk of fractures elsewhere in the body by just

over half.

The study was stopped early because of a cancer scare resulting from other Lilly

research in which scientists found that rats developed bone cancer when given

high lifelong doses of the drug.

However, researchers eventually decided that the results do not suggest a

higher cancer risk in people. Among other things, people with naturally high

levels of the hormone as a result of overactive parathyroid glands are not

especially prone to bone cancer, and none of the women in this or earlier

studies of the hormone has developed the cancer.

The entire parathyroid hormone contains 84 amino acids. Forteo is a 34-amino

acid portion of this. Experts believe it does the same job as the full hormone.

------

[Guest guest]

Re: the last sentence of Gail's post. I was one of the women in the " earlier

studies " of hPTH (1-34) for use in hypoparathyroidism. It has not been long

enough to know if we will get bone cancer in the future.

From the New York Times, about an article in today's New

England Journal of Medicine:

May 9, 2001

Natural Hormone Helps Osteoporosis

By THE ASSOCIATED PRESS

BOSTON (AP) -- A natural bone-building hormone appears to be the most effective

treatment ever for osteoporosis, the brittle bone disease that afflicts millions

of older Americans.

The manufacturer hopes the medicine, called Forteo (for-TAY-oh), will be

available by prescription by the end of the year. If so, it is likely to be

recommended for victims of moderate to severe osteoporosis, a condition blamed

for more than 1.5 million fractures annually in the United States.

The drug is based on the parathyroid hormone, which is ordinarily secreted by

tiny glands in the neck. When given to volunteers with osteoporosis, it doubles

their normal rate of bone formation.

A study in Thursday's New England Journal of Medicine shows that it dramatically

reduces the risk of broken bones. The risk of spinal fractures, a hallmark of

osteoporosis, fell by two-thirds in women getting the medicine.

Other osteoporosis drugs on the market, such as Fosamax, work by slowing the

body's loss of bone. Forteo is the only treatment that actually prompts the body

to make new bone.

But unlike the other medicines, Forteo has a major drawback: It can be

administered only by daily injections. Still, doctors say patients quickly

master this process, which is similar to insulin injections, and no serious side

effects were seen.

``It's the first demonstration of the concept that stimulating bone formation is

going to be an effective way to treat osteoporosis in humans,'' said Dr.

M. Neer of Massachusetts General Hospital, the study's director.

The medicine, known generically as teriparatide, is being developed by Eli

Lilly, which financed the study.

Dr. Felicia Cosman of Helen Hospital in West Haverstraw, N.Y., clinical

director of the National Osteoporosis Foundation, estimated that 25 percent to

30 percent of osteoporosis patients might be considered for treatment with the

new drug.

``It represents a lot of hope for the future for women with severe osteoporosis,

especially those who are on the best drugs and still having fractures,'' she

said.

The foundation estimates that 10 million Americans -- 80 percent of them female

-- have osteoporosis. Broken vertebrae, hips and wrists are especially common.

The latest study was conducted on 1,637 postmenopausal women who had suffered at

least one fracture because of osteoporosis. They were randomly assigned to take

either 20 or 40 micrograms of the hormone or dummy shots. After 18 months of

treatment, women taking the higher dose of drug had 13 percent more bone in

their spines than did those on the placebo.

Forteo has not been compared directly to other drugs, so doctors cannot say for

sure that it is truly better. However, the results of this and other studies

with the new medicine are more impressive than those typically seen with other

drugs. For instance, the researchers said the largest increase in bone seen with

other drugs was 9 percent.

Forteo reduced the occurrence of new vertebral fractures by 65 percent or 69

percent, depending on whether women got the high or low dose. Neer said no other

drug has reduced it by more than 40 percent to 50 percent.

The new drug reduced the risk of multiple spinal fractures by 77 percent or 86

percent, and it lowered the risk of fractures elsewhere in the body by just

over half.

The study was stopped early because of a cancer scare resulting from other Lilly

research in which scientists found that rats developed bone cancer when given

high lifelong doses of the drug.

However, researchers eventually decided that the results do not suggest a

higher cancer risk in people. Among other things, people with naturally high

levels of the hormone as a result of overactive parathyroid glands are not

especially prone to bone cancer, and none of the women in this or earlier

studies of the hormone has developed the cancer.

The entire parathyroid hormone contains 84 amino acids. Forteo is a 34-amino

acid portion of this. Experts believe it does the same job as the full hormone.

------

[Guest guest]

and Gail,

Was the drug an injectible Eli Lilly product? There was a

rheumatologist on a TV show last week who thought this was going

to be a beneficial osteoporosis med. Some of her patients were in

the trials, but its not approved in Canada yet and won't be for

1-2 years.

Since it's some kind of synthetic pt hormone, I asked if it would

be used for hypo pt patients who were totally lacking pt glands

but she didn't know, she said that wasn't her area of expertise,

she was interested in its beneficial effects on bones.

I was going to e-mail Eli Lilly but only got an address to write

to but I think the

drug is Forteo and involves a daily injection. Did your study use

this drug, , and was it for osteoporosis or hypoparathyroidism?

Please has anyone else any info?

Thanks and best wishes to all,

Diane (Thycan spouse).

[Guest guest]

and Gail,

Was the drug an injectible Eli Lilly product? There was a

rheumatologist on a TV show last week who thought this was going

to be a beneficial osteoporosis med. Some of her patients were in

the trials, but its not approved in Canada yet and won't be for

1-2 years.

Since it's some kind of synthetic pt hormone, I asked if it would

be used for hypo pt patients who were totally lacking pt glands

but she didn't know, she said that wasn't her area of expertise,

she was interested in its beneficial effects on bones.

I was going to e-mail Eli Lilly but only got an address to write

to but I think the

drug is Forteo and involves a daily injection. Did your study use

this drug, , and was it for osteoporosis or hypoparathyroidism?

Please has anyone else any info?

Thanks and best wishes to all,

Diane (Thycan spouse).

[Guest guest]

and Gail,

Was the drug an injectible Eli Lilly product? There was a

rheumatologist on a TV show last week who thought this was going

to be a beneficial osteoporosis med. Some of her patients were in

the trials, but its not approved in Canada yet and won't be for

1-2 years.

Since it's some kind of synthetic pt hormone, I asked if it would

be used for hypo pt patients who were totally lacking pt glands

but she didn't know, she said that wasn't her area of expertise,

she was interested in its beneficial effects on bones.

I was going to e-mail Eli Lilly but only got an address to write

to but I think the

drug is Forteo and involves a daily injection. Did your study use

this drug, , and was it for osteoporosis or hypoparathyroidism?

Please has anyone else any info?

Thanks and best wishes to all,

Diane (Thycan spouse).

[Guest guest]

Diane,

The study I was in was not for Eli Lily. I was in the study of

the drug before it had the " Brand Name " of Forteo It was

synthetic human (h) Parathormone (PTH)-- hPTH (1-34)

The trial was for use in treating hypoparathyroidism. It appears

at this point that this preparation will not be available for

use in the US for hypoparathyroidism. It is expected to be

marketed by the end of the year for use in osteoporosis as the

article said. The drug in my trial was injectable.

from NE Ohio

=====

Irradiation to thymus as infant

3/25/65 tt Pap thyca w/lymph node mets

Hypoparathyroidism 3 days post radical tt

3/25/82 Recurrence in neck & R chest

Tx w/ 176 mCi RAI 131

hx kidney stones

No scan- 5/22/01 after TSH 38.2 & Tg <0.9 & TgAb <2.0

__________________________________________________

[Guest guest]

Diane,

The study I was in was not for Eli Lily. I was in the study of

the drug before it had the " Brand Name " of Forteo It was

synthetic human (h) Parathormone (PTH)-- hPTH (1-34)

The trial was for use in treating hypoparathyroidism. It appears

at this point that this preparation will not be available for

use in the US for hypoparathyroidism. It is expected to be

marketed by the end of the year for use in osteoporosis as the

article said. The drug in my trial was injectable.

from NE Ohio

=====

Irradiation to thymus as infant

3/25/65 tt Pap thyca w/lymph node mets

Hypoparathyroidism 3 days post radical tt

3/25/82 Recurrence in neck & R chest

Tx w/ 176 mCi RAI 131

hx kidney stones

No scan- 5/22/01 after TSH 38.2 & Tg <0.9 & TgAb <2.0

__________________________________________________