Combination Osteogenic Therapy in Established Osteoporosis

Completed · Phase 2

Conditions studied: Osteoporosis, Post-Menopausal

In brief

This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR) therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e., decreased bone formation and no further increase in bone density) that is observed within 18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an increase in bone density which is maintained after treatment is discontinued.

Key facts

Study ID

NCT00018447

Run by

US Department of Veterans Affairs

Starts

1998-11-01

Expected to finish

2003-10-01

Last updated by the study team

2009-01-21

Who can join

Age: 60 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• More than 1 vertebral fracture in lumbar spine or more than 4 fracture in the T-L spine.
• Weight less than 45 kg or more than 80 kg, or more than 25% above ideal body weight.
• Present cardiac disease present.
• Diseases or conditions known to affect bone metabolism.
• Therapies with drugs that affect bone metabolism within 6 months.
• Fluoride or Biophosphonates at any time.

Where it is running

• Jerry L. Pettis Memorial Veterans Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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