I am glad to report that at least four members have called (or mailed) me
with pertinent osteoporosis information this
quarter. Virgil Kruel sent along a clipping from the LA Times from November 10, 1997. That paper reported that
alendronate (Fosamax) has been shown to be effective for both men and women who are taking corticosteroids for
treatments such as rheumatoid arthritis, asthma, and inflammatory bowel diseases. Researcher, Dr. Ken Saag of the
University of Iowa, at a meeting of the American College of Rheumatology in Washington, D.C., noted that this is the first
time any drug for osteoporosis has been shown to work in men. Tomme Hartgrove called to tell me about three
osteoporosis-related issues. While at a sporting goods store, he spoke to an expert shooter who told him that men in their
seventies often suffer broken shoulders from shooting shotguns. This is especially true for large gauge guns like the
12-gauge. This is probably also a concern for men who are younger but who have osteoporosis. If you are a shooter, be
aware of the potential for injury. He also mentioned a calcium product called Bone Up from Jarrow Formulas, Inc. This is
a microcrystalline hydroxyapatite calcium supplement that is touted by the manufacturer as highly effective. The company
can be reached at 800-726-0886 and 1824 So. Robertson Blvd, L.A., CA 90035. I have called them for literature which
they are sending. I will report on any significant research done on their product in next quarter`s newsletter. Tomme, an
avid skier, has had his skiing curtailed considerably by osteoporosis. He mentioned that a new product for skiers has just
been introduced called snow biking. The bike has a front and rear ski and the rider wears small skis, too. There is a front
wheel that allows the driver to turn the bike and easily traverse the snow. It appears that it would be very difficult to fall
from this bike so it might be a welcome addition to the recreational activities of those of us with osteoporosis who love to
ski. Tomme will be trying the snow bike out this winter and will give a further report in the next issue. Hank Daneman
e-mailed me with information on a significant study concerning using calcium and vitamin D to improve bone density in
men and women more than 65 years of age. The New England Journal of Medicine 1997 Sept 4;337(10):670-6 is the
reference for this study. The authors looked at the effects of three years of dietary supplementation with calcium and
vitamin D on bone mineral density (BMD). The calcium dose was either 500 mg, plus 700 IU of vitamin D3 per day, or
placebo. They found over a three-year period the men and women more than 65 years of age or older had moderately
reduced bone loss measured in the femoral neck, spine, and total body. They also noted a reduced incidence of non
vertebral fractures. In fact, the calcium/vitamin D supplement group had half the fractures from falls as the placebo group.
Last, but not least, Fraser Lang sent me a copy of another health newsletter with a two-page report on men with
osteoporosis. He got permission to reprint the article that will be printed with this issue. Thanks very much to all who sent
information.
Now for the bad news on this group support issue. Dick Richards reports that as of December 1, 1997, he has heard from
only one member beside me concerning his request for information about men taking Fosamax. In last quarter`s newsletter
he asked for members to call, write, or e-mail him with information about whether they were taking Fosamax, if their HMO
was paying for it, etc. I don`t know if it is too late to contact him, but I know he would appreciate hearing from everyone in
the group.
I recently received the Boning Up on Osteoporosis booklet from the National Osteoporosis Foundation. This booklet is an
excellent source of information on osteoporosis and I recommend it highly. It is brief yet covers all the essentials in
adequate detail. Contact the National Osteoporosis Foundation for copies or information.
Two members who have been taking Fosamax for at least one year have reported results of recent bone scans. One reports
that the spine is "greatly improved," but with no change in the hips. Another reports a 5% spine improvement over the last
year, in addition to improvements that occurred the first year he was on Fosamax. He also reports no gain (but no loss) in
hip BMD. So, the excellent results for increasing spinal BMD continue after taking Fosamax. The lack of improvement in
hip BMD unfortunately also continues.
Here is an interesting anecdote that a member sent me. The technician that administers his bone scans was having a slow
day so he gave himself a bone scan. The results shocked him so he immediately saw his physician. Osteoporosis was
diagnosed and he is now on Fosamax for three months with reported monthly improvements in spinal BMD. (Since he
controls the machine, he gives himself monthly bone scans.)
No one sent member profile information so I will discontinue that section in this and future newsletters unless someone
submits their data. Future editions will not be as structured as previous ones either. I will only print a segment if I have
room or if there is an important issue concerning that topic.
Please note the change in the subscription information this quarter. Although I will gladly continue to send the newsletter to
everyone free, I would like to hear from everyone at least once per quarter. If I don`t hear for two consecutive quarters, I
will stop your subscription assuming you are no longer interested. Use a $.20 postcard, e-mail, letter, or call-whichever you
prefer. In particular, tell me if there is anything else you would like to include in future newsletters. The idea of the
newsletter is that it is the focus point of group interaction for men with osteoporosis. Rather than each of us writing or
calling all the other members, tell me so I can inform all the members about your news, concerns, suggestions, criticism,
etc., via the newsletter. If this creates a problem for anyone, please let me know. My hope is that everyone will benefit from
the change. Would you like me to include a poll of the members as part of this system? For instance, we could ask how
many members are on Fosamax, the results they`ve had since starting, if any are on Miacalcin, etc. Each quarter I could
post results of that quarter`s survey in the next newsletter. When you contact me this quarter, let me know if this would
interest you and what you would like included in the surveys, if appropriate.
Ask the Experts
I am happy to announce that Dr. Felicia Cosman, a noted osteoporosis researcher and clinician, will be answering questions
from men`s support group members. Dr. Cosman is an endocrinologist and osteoporosis expert at Helen Hayes Hospital in
West Haverstraw, NY. She is also the Clinical Director of the National Osteoporosis Foundation in Washington, D.C. and
Associate Professor of Clinical Medicine at Columbia University, New York, NY. The first questions for her are about her
work on a recent study that found significantly increased BMD in women receiving parathyroid hormone therapy.
BACKGROUND
Dr. Cosman and fellow researchers (1) did a three-year randomized controlled trial to find out the effects of 1-34 human
parathyroid hormone (1-34 PTH). PTH has been shown in animal studies to stimulate new bone formation, increase bone
mass, and improve bone strength. Seventeen postmenopausal women received daily injections of hormone for three years
in addition to hormone therapy, and 17 women (controls) took hormone-replacement therapy (HRT) only. Patients taking
PTH plus HRT had continuously increased vertebral BMD during the three years. Women in the control group had no
significant change in BMD during the same period. Total increase in vertebral, hip, and total-body BMD was 13%, 2.7%,
and 8%, respectively. Increased bone mass was associated with a reduction in the rate of vertebral fractures. Evaluation of
bone markers showed evidence of early stimulation of bone formation suggesting stimulation of osteoblasts. Note that this
effect is the opposite of alendronate that works by blocking bone resorption.
QUESTIONS
Note is made of the above-mentioned article as discussed in the Fall 1997 issue of Osteoporosis Report. The findings of
13% increase in spinal BMD are quite noteworthy. Yet I have seen only the one report on your study in the National
Osteoporosis Foundation newsletter. Have I missed other publications and announcement about the study? If not, can you
explain why it hasn`t been covered more by the mass media? Do you think that this therapy would work just as well for
males? When will additional trials begin with this method? What are the risks with it? We have at least one man in our
group that desperately could use such results to rebuild his bones. How could he volunteer for official or unofficial trials of
the 1-34 PTH?
ANSWERS
The announcements about the study have been somewhat limited. I think this is due to the fact that the data were presented
about two years ago at our bone meetings and received quite a lot of attention at that time. Still, I think that the media
attention was under represented for what I think is a very important study. There have been two other controlled clinical
trials using PTH, and both were in women. The first was in 1994 in the New England Journal of Medicine (2) looking at
premenopausal women with acute estrogen deficiency as a result of treatment for endometriosis. A more recent study was
done on women with osteoporosis in JCEM in 1997 by Hodsman (3) This was a different dose of parathyroid hormone,
essentially twice the dose that we used. Additionally, it was used only one month out of three, making the protocol quite
different from ours. Still, it looked quite effective.
In fact, a study is currently ongoing using 1-34 PTH in men. This trial started about one and one-half years ago as a
blinded, randomized, controlled clinical trial. The preliminary results at one year showed a significant improvement in bone
mass in the PTH-treated group. There will, therefore, be an open extension with everybody receiving PTH starting in
December 1997 for an additional one and one-half years. The study is a phase-two study sponsored by a small biotech
company called Biomeasure, Inc., based in Massachusetts with a French parent company.
Additional trials are also underway in postmenopausal women with osteoporosis. The trials are in steroid-treated
osteoporosis with women on estrogen and parathyroid hormone similar to the trial that we published in The Lancet.
Furthermore, there is another study using the compound 1-84 PTH that has been investigated in women without any
ongoing hormonal therapy that is completed. The data are unpublished and are still being analyzed.
The fears with regard to the side effects of PTH are that it might be detrimental to the cortical part of the skeleton: namely
the hip and perhaps the forearm. That is why, when we designed the study, we used estrogen in addition to the PTH to
protect the cortical part of the skeleton. There are few data to support this concept. The data using 1-84 PTH on the hip
and total body have to be scrutinized for that aspect. Furthermore, the data in the ongoing study in men has to be
scrutinized for any negative effects on the hip or forearm. These data should be available in approximately the next one and
one-half years. Other risks with PTH include hypercalciuria that is apparently quite rare at the dose of 400 IU per day that
we are using. A theoretical complication of the hypercalciuria is an increase of the risk of kidney stones. This has not been
documented in any of the clinical trials so far published. Because of this theoretical concern, men and women who have
had multiple kidney stones or kidney stones within the last five years are not good candidates for PTH treatment. An
additional possible side effect is that of allergy and delayed allergic reactions, including subcutaneous nodule formation. As
you see in our paper, we did find these nodules in more than one of our patients, perhaps related to a specific batch of the
PTH as an impurity associated with that.
The same company that is currently sponsoring the PTH trial in men is planning a phase-three study which is going to be a
multi- center study. This might be available to the patient you mentioned in your letter. I will try to get the list of sites for
that study when they become available. As of yet, however, the exact protocol has not been finalized as it is pending
approval by the FDA.
Please let me know if you have any further questions regarding PTH therapy. I do think that it has potential to be quite
useful in both women and men, and probably in combination with other agents. This may be especially so for men and
women with particularly severe vertebral osteoporosis as its beneficial effect seems most prominent at that site. The really
important issue that we found in our study was that there was a reduction in vertebral deformity associated with the increase
in bone mass. This implies that it would reduce the risk of vertebral fracture and that the bone formed under the influence
of PTH is of normal quality and strength. This has been an issue for sodium fluoride, the other drug in the "anabolic" class.
Sodium fluoride appears to increase bone mass but may not reduce the risk of fracture.
1. Lindsay R, Nieves J, Formica C, Henneman E, Woelfert L, Shen V, Dempster D, Cosman F.Randomized
controlled
study of effect of parathyroid hormone on vertebral-bone mass and fracture incidence among postmenopausal women on
oestrogen with osteoporosis. Lancet 1997; 350: 550-555.
2. Finkelstein JS, Klibanski A, Schaefer EH, Hornstein MD, Schiff I, Neer RM. Parathyroid hormone for the prevention of
bone loss induced by estrogen deficiency. N Engl J Med 1994;331:1619-1623.
Hodsman AB, Fraher LJ, Watson PH, Ostbye T, Stitt LW, Adachi JD, Taves DH, Drost D. A randomized controlled trial
to compare the efficacy of cyclical parathyroid hormone versus cyclical parathyroid hormone and sequential calcitonin to
improve bone mass in postmenopausal women with osteoporosis. J Clin Endo Met 1997;82:620-628.
Osteoporosis in men
The last two pages of this newsletter contain the reprinted article on osteoporosis in men from Volume 3, August 26, 1997,
of HealthNews, copyright 1997 Massachusetts Medical Society. All rights reserved. Yearly subscriptions to HealthNews
cost $29.00.For subscription information, send inquiries to HealthNews, P.O. Box 52924, Boulder, CO 80322-2924.
Thanks again to Fraser Lang for sending the article and for arranging for permission to reprint the article from the
publishers. NOTE: This article is not included on the Web page newsletter edition.
Disclaimer
Diagnosis and treatment of osteoporosis are the responsibility of the patient and his or her physician. Nothing in this
newsletter is to be interpreted as a recommendation for treatment or to change treatment that your physician has prescribed.
Although we attempt to assure that information in this newsletter is factual, errors will occur. It is the responsibility of the
reader to verify that information they are acting on is factual. There is no relationship between this newsletter and any
national osteoporosis group, including the National Osteoporosis Foundation. All references to any such groups are for
informational purposes only.
