Alendronate and/or Parathyroid Hormone for Osteoporosis

Completed · Phase 2

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00000400

Run by

Massachusetts General Hospital

People needed

176

Starts

1999-08-01

Expected to finish

2006-06-01

Last updated by the study team

2013-12-09

Who can join

Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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