Combination Osteogenic Therapy in Established Osteoporosis

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.

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Key information

Conditions

Osteoporosis, Post-Menopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Jerry L. Pettis Memorial Veterans Medical Center

Loma Linda, California, 92357, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PTH 1-34

Drug

MFPSR-fluoride

Drug

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start: 1998
Study completion: 2003
First posted: Jul 5, 2001
Registry last updated: Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed