Osteoporosis and Dental Implant | NCT00727493

Studies
Osteoporosis and Dental Implant

NCT00727493

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Aug 4, 2008Estimated

Enrollment

45Estimated

Phase

Phase 4

Conditions

Osteoporosis

Interventions

alendronate once weekly 70mg
placebo

Countries

Germany

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

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Jan 2010Estimated

Completion Date

Apr 2010Estimated

First Submitted Date

Jul 31, 2008

First Submission Date that Met QC Criteria

Aug 1, 2008

First Posted Date

Aug 4, 2008Estimated

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

Aug 1, 2008

Last Update Posted Date

Aug 4, 2008Estimated

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 influence of alendronate therapy on the wound healing after dental implants in patients with osteoporosis.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily, dental implant	Drug: alendronate once weekly 70mg
2	Placebo Comparator	placebo once weekly, calcium 1000mg and Vitamin D 800 IU daily; dental implant	Drug: placebo
3	No Intervention	dental implant, calcium 1000mg and Vitamin D 800 IU daily

Interventions

Name	Type	Description	Arm Group Labels	Other Names
alendronate once weekly 70mg	Drug	alendronate once weekly 70mg, calcium 1000mg and Vitamin D 800 IU daily for 12 months, dental implant	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dental CT		baseline, and 3,6,12 months after baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women > 2 years after menopause
Age between 60 and 75 years
Possibility to insert a dental implant
Osteoporosis as defined by WHO criteria (intervention group), or women without osteoporosis / osteopenia (non-intervention group)

Exclusion Criteria:

Pathological findings in the jaw bone
Chronic inflammatory rheumatoid disease
Bisphosphonate treatments during the last 12 months
Inflammatory or metabolic bone disease, excluding osteoporosis
Systemic corticosteroid treatments of more than one month within previous 12 months
Severe diseases with life expectancy less than one year or expectation of rapid worsening within one year

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dieter Felsenberg, Prof. Dr.	Contact	+490384453046		dieter.felsenberg@charite.de
Hendrikje Boerst, Dipl. Wiss org.	Contact	+490384454745		hendrikje.boerst@charite.de

Overall Officials

Name	Affiliation	Role
Dieter Felsenberg, Prof. D.r	Leader of the center for muscle and bone research, Charité	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin	Recruiting	Berlin		12200	Germany

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided