Combination Osteogenic Therapy in Established Osteoporosis - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018447

Purpose

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
Official Title:	Combination Osteogenic Therapy in Established Osteoporosis

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Fluoride

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Study Start Date:	November 1998
Estimated Study Completion Date:	October 2003

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.

Eligibility

Ages Eligible for Study:	60 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018447

Locations

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

Sponsors and Collaborators

Department of Veterans Affairs

More Information

No publications provided

Study ID Numbers:	ENDO-022-98S
Study First Received:	July 3, 2001
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00018447 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:

osteoporosis

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic

Fluorides
Bone Diseases
Menopause

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on July 02, 2009