Combination Osteogenic Therapy in Established Osteoporosis

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Fluorides

Criteria

• Female, aged 60-80,

• Postmenopausal greater than or equal to 5 years,

• BMD -2.5 to -4.0 at lumbar spine or femoral neck and one standard deviation below young adult mean in the other site, or -2.0 with fracture.

• Vertebral fracture 0-1.

Exclusion Criteria:

• 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.