Clinical Trials Logo
  1. Home
  2. Osteopenia
  3. NCT00004488
  4. Details
NCT00004488 Clinical Trial

Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease

Osteopenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004488
Other study ID # 199/14269
Secondary ID CHMC-C-FDR001537
Status Completed
Phase Phase 2
First received October 18, 1999
Last updated March 24, 2015
Start date October 1998
Est. completion date September 2002

Study information
Verified date March 2000
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.

Description:

PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled study.

All patients receive oral calcium carbonate and cholecalciferol daily. Patients are randomized to receive oral alendronate sodium or placebo daily for 24 months.

Patients are followed every 6 months for 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date September 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of type 1 Gaucher's disease enzymatically proven to have acid beta glucosidase deficiency

Must have been on stable dose (8-60 U/kg/every 2 weeks) of alglucerase enzyme therapy (Cerezyme or Ceredase) for at least 24 months

Lumbar spine bone density below the mean for age, sex, and race

--Prior/Concurrent Therapy--

At least 6 months since prior medications that directly affect skeletal metabolism including, but not limited to, bisphosphonates, calcitonin, parathyroid hormone, or estrogen

--Patient Characteristics--

Renal: No chronic renal failure; No recurrent renal stones

Esophageal: No history of dysphagia; No frequent heartburn; No esophagitis requiring treatment

Other: No untreated hyperthyroidism or hypothyroidism; No concurrent hyperparathyroidism; No concurrent malignancy; No history of alcohol or drug abuse; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• alendronate sodium

• calcium carbonate

• cholecalciferol

Locations
Country Name City State
Israel Shaare Zedek Medical Center Jerusalem
United States Children's Hospital Medical Center - Cincinnati Cincinnati Ohio
United States Wright State University School of Medicine Dayton Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Countries where clinical trial is conducted

United States,  Israel, 

See also
  Status Clinical Trial Phase
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Active, not recruiting NCT05066477 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women N/A
Terminated NCT01902186 - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir Phase 4
Completed NCT01439139 - Bone UltraSonic Scanner (BUSS): Validation Study N/A
Not yet recruiting NCT01397838 - Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women Phase 1
Completed NCT01222026 - Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate Phase 4
Completed NCT00789425 - Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women Phase 2
Completed NCT01152580 - Melatonin Osteoporosis Prevention Study Phase 1
Completed NCT00655681 - Prevention of Post Operative Bone Loss in Children N/A
Completed NCT00463268 - Osteoporosis Prevention With Low Dose Alendronate Phase 3
Completed NCT00798473 - Zoledronate for Osteopenia in Pediatric Crohn's Phase 3
Active, not recruiting NCT00076050 - Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms Phase 3
Completed NCT00226031 - Optimal Management of Women With Wrist Fractures N/A
Enrolling by invitation NCT04752098 - A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method N/A
Completed NCT04720833 - Effect of Dried Plum on Bone and Markers of Bone Status in Men N/A
Recruiting NCT05541432 - Finding the Optimal Resistance Training Intensity For Your Bones N/A
Active, not recruiting NCT05405894 - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Completed NCT05457036 - Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile N/A
Completed NCT04040010 - The Effects of Bovine Colostrum in Bone Metabolism in Humans N/A
Completed NCT02731820 - Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia N/A