Osteoporosis Prevention With Low Dose Alendronate | NCT00463268

Studies
Osteoporosis Prevention With Low Dose Alendronate

NCT00463268

Sponsor

University Hospital of Mont-Godinne

Status

Completed

Last Update Posted

May 29, 2013Estimated

Enrollment

83Actual

Phase

Phase 3

Conditions

Osteopenia

Interventions

alendronate
Calcium/Vitamin D
placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Apr 19, 2007

First Submission Date that Met QC Criteria

Apr 19, 2007

First Posted Date

Apr 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2013

Last Update Posted Date

May 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Boutsen Yves, professeur, University Hospital of Mont-GodinnePrincipal Investigator

Lead Sponsor

University Hospital of Mont-GodinneOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Alendronate 70 mg every 2 weeks	Drug: alendronate Dietary Supplement: Calcium/Vitamin D
2	Placebo Comparator	Alendronate 70 mg placebo tablet every 2 weeks	Dietary Supplement: Calcium/Vitamin D Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
alendronate	Drug	alendronate 70 mg every 2 weeks	1
Calcium/Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of lumbar BMD modification after 2 years		2 years

Secondary Outcomes

Measure	Description	Time Frame
percentage of hip BMD modification (total hip and sub-regions)		2 years
percentage of modification of bone remodeling markers		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yves R Boutsen, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University (UCL) Louvain Hospital in Mont-Godinne		Yvoir	Namur	5530	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019386	Alendronate
D002118	Calcium
D014807	Vitamin D

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided