Alendronate and/or Parathyroid Hormone for Osteoporosis

Status

Completed

Phase

Phase 2

Enrollment

176 participants (actual)

Sponsor

Massachusetts General Hospital · Other

Design

Randomized · Open label (no masking)

Countries

1 country

United States

Start

Aug 1999

Primary completion

Apr 2006

Completion

Jun 2006

First posted

4 Nov 1999 (estimated)

Last update posted

9 Dec 2013 (estimated)

Conditions

Osteoporosis

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.

• Experimental

  PTH

  Human parathyroid hormone \[hPTH-(1-34)\]

• Active comparator

  ALN

  Alendronate

• Experimental

  PTH+ALN

  Human parathyroid hormone \[hPTH-(1-34)\] plus alendronate

1. change in spine bone mineral density

   Time frame · study months 30 (phase A), 42 (phase B), 54 (phase C)