Combination Osteogenic Therapy in Established Osteoporosis

NCT ID: NCT00018447

Last Updated: 2009-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-11-30
• Study Completion Date: 2003-10-31

Brief 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.

Detailed Description

This is a 3-yr, single center, open label, active controlled, randomized study of approximately 99 postmenopausal females with osteoporosis of spine or femoral neck. Patients will be assigned to 1 of 3 groups: 1) PTH 1-34; 2) Fluoride; 3) PTH and fluoride. The treatment period is 3 years with 3-month cycles of therapy. PTH will be administered subcutaneously by injection 600 units daily for 28 days the first month of each 3-month cycle. Fluoride will be administered orally one 76mg tablet twice daily (providing 20 mg fluoride/day), during the last 2 months of each cycle. Calcium will be provided 800mg/day during month 1 and 1500-2000mg for months 2 and 3 of each cycle.

Conditions

Osteoporosis, Post-Menopausal

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

PTH 1-34

Intervention Type: DRUG

MFPSR-fluoride

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Locations

Jerry L. Pettis Memorial Veterans Medical Center

Loma Linda, California, United States

Countries

United States

Other Identifiers

ENDO-022-98S

Identifier Type: -

Identifier Source: org_study_id