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.

Condition	Treatment or Intervention	Phase
Osteoporosis, Post-Menopausal	Drug: PTH 1-34  Drug: MFPSR-fluoride	Phase II

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.

Ages Eligible for Study:  60 Years   -   80 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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: 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.

California
      Jerry L. Pettis Memorial Veterans Medical Center, Loma Linda,  California,  92357,  United States; Recruiting

Study ID Numbers:  ENDO-022-98S
Record last reviewed:  June 2001
Record first received:  July 3, 2001
ClinicalTrials.gov Identifier:  NCT00018447
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-16