Combination Osteogenic Therapy in Established Osteoporosis - Full Text View

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

MedlinePlus related topics:

Osteoporosis

ChemIDplus related topics:

Fluoride Sodium fluoride Stannous fluoride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label

Official Title:	Combination Osteogenic Therapy in Established Osteoporosis

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

Study ID Numbers:	ENDO-022-98S
First Received:	July 3, 2001
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00018447
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

ClinicalTrials.gov processed this record on October 10, 2008

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