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Anabolic Actions of PTH in Osteoporotic Men
NCT00000427Phase 3
Key facts
- Status
- Completed
- Start
- Sep 1999
- Primary completion
- Oct 2005
- Countries
- 1
- Sponsor
- Massachusetts General Hospital
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- osteoporosis
01
Overview
Phase 3, randomised trial of parathyroid hormone 1-84 in osteoporosis (3 arms), sponsored by Massachusetts General Hospital. Primary endpoint: Bone Mineral Density at 30 months. Started Sep 1999; status: completed.
02
Design
3 arms- Study design
- Randomized
PTH alone
Parathyroid hormone alone by daily injection under the skin
Alendronate alone
Alendronate alone taken by mouth
PTH + Alendronate
Both PTH and alendronate
03
Who it enrols
Men with osteoporosis (bone density 2 SD below young adult mean) with normal organ function and hormone levels, excluding those with diseases or prior drugs affecting bone metabolism.
04
Endpoints
Primary
Bone Mineral Density
Secondary
Bone Turnover Markers
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