Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00463268
Other study ID # MG/OP 001
Secondary ID
Status Completed
Phase Phase 3
First received April 19, 2007
Last updated May 28, 2013
Start date September 2007
Est. completion date January 2012

Study information

Verified date May 2013
Source University Hospital of Mont-Godinne
Contact n/a
Is FDA regulated No
Health authority Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 60 Years
Eligibility Inclusion Criteria:

- 45 to 60 year-old women

- Menopausal since at least 6 months

- Baseline lumbar BMD from -1 till -2.5

Exclusion Criteria:

- Bone disease other than osteopenia

- Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization

- Former or current treatment with any bisphosphonate or bone forming agents

- Chronic use of oral or iv corticosteroids

- Any diagnosis of malignancy less than 12 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
alendronate
alendronate 70 mg every 2 weeks
Dietary Supplement:
Calcium/Vitamin D
Calcium 500 mg and vitamin D supplementation according to serum level
Drug:
placebo
identical placebo every 2 weeks

Locations

Country Name City State
Belgium University (UCL) Louvain Hospital in Mont-Godinne Yvoir Namur

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Mont-Godinne

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of lumbar BMD modification after 2 years 2 years No
Secondary percentage of hip BMD modification (total hip and sub-regions) 2 years No
Secondary percentage of modification of bone remodeling markers 2 years No
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 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
Completed NCT05721014 - Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health N/A