This study looks at the effects of two medications, alendronate and parathyroid hormone, on
bone mass and on bone formation and bone breakdown in women with osteoporosis. We will
randomly select postmenopausal women who have osteoporosis to receive laboratory-produced
human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants
will return to the study center periodically to have their bone mass measured and to give
blood and urine samples for tests of bone formation and breakdown and for other laboratory
tests. Those who complete the study are eligible for one or two 12 month extension studies.
This is a randomized, prospective, open-label study in which osteoporotic postmenopausal
women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years.
Participants initially come to Massachusetts General Hospital once a month, and subsequently
once every 3-6 months, for measurements of serum and urine indices of bone formation and
resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third
of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and
one-third take both daily (Phase A, months 0-30).
Participants who complete Phase A are eligible for a 12 month extension study (Phase B,
months 30-42), during which any alendronate treatment is continued without change and any
hPTH 1-34 treatment is stopped.
Participants who complete Phase B are eligible for a second 12 month extension study (Phase
C, months 42-54), during which any alendronate treatment is continued without change and
every participant takes hPTH 1-34.
During Phases B and C, these participants come to Massachusetts General Hospital once every
6 months for measurements of serum and urine indices of bone formation and resorption, serum
and urine toxicity tests, and DXA/QCT measurements of bone mass.
- Lumbar spine or hip BMD T-score less than or equal to minus 2.0
- Postmenopausal at least 5 years
- Fully ambulatory
- Able to give informed consent
- No concurrent illnesses that cause bone loss
- No recent drug treatment for osteoporosis
- No recent fracture