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.

Condition	Treatment or Intervention	Phase
Osteoporosis	Drug: Human parathyroid hormone [hPTH-(1-34)]	Phase II

Further Study Details: 

Expected Total Enrollment:  108

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 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.

Ages Eligible for Study:  45 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Lumbar spine or hip BMD T-score < or = minus 2.0
• Postmenopausal at least 5 years
• Must be fully ambulatory
• Must be able to give informed consent

Exclusion Criteria:

• No concurrent illnesses that cause bone loss
• No recent drug treatment for osteoporosis
• No recent fracture

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

Robert M. Neer, MD,  Principal Investigator,  Massachusetts General Hospital   

Study ID Numbers:  NIAMS-023; P50 AR44855
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00000400
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08