NCT00386360

Brief Summary

The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2006

Typical duration for phase_3

Geographic Reach
7 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 11, 2012

Completed
Last Updated

January 11, 2012

Status Verified

October 1, 2011

Enrollment Period

3.4 years

First QC Date

October 9, 2006

Results QC Date

August 12, 2011

Last Update Submit

December 6, 2011

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

  • Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12

    Baseline and Month 12

Secondary Outcomes (13)

  • Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12

    Baseline and Month 12

  • Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12

    Baseline and Month 12

  • Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12

    Baseline and Month 12

  • Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

    Baseline and Month 12

  • Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

    Baseline and Month 12

  • +8 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo dose

Drug: Placebo comparator

Risedronate

EXPERIMENTAL

35 mg risedronate, orally, once weekly

Drug: risedronate

Interventions

Placebo comparatorDRUG

oral weekly for one year

Placebo
risedronateDRUG

35 mg risedronate, once a week for one year

Risedronate

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
  • osteopenic
  • must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
  • BMI (body mass index) between 18 and 28 kg/m2 inclusive;

You may not qualify if:

  • history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
  • clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (\* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
  • glucocorticoid-induced osteopenia;
  • previous bisphosphonate therapy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Facility

Buenos Aires, Buenos Aires, C1012AAR, Argentina

Location

Research Facility

Heidelberg, Victoria, 3081, Australia

Location

Research Facility

Toronto, Ontario, M5G 2C4, Canada

Location

Research Facility

Lyon, Lyon, France

Location

Research Facility

Saint-Etienne, Saint-Etienne, France

Location

Research Facility

Toulouse, Toulouse, France

Location

Research Facility

Berlin, State of Berlin, Germany

Location

Research Facility

Geneva, Canton of Geneva, Switzerland

Location

Research Facility

Cambridge, Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Grexan Wulff, Manager Regulatory Affairs
Organization
Warner Chilcott
gwulff@wcrx.com
973-442-3376

Study Officials

  • Gioacchino D'Alo, MD

    P&G Pharmaceuticals, Clinical Development Europe

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 11, 2006

Study Start

April 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 11, 2012

Results First Posted

January 11, 2012

Record last verified: 2011-10

Locations

GB(1)AR(1)CA(1)AU(1)FR(3)DE(1)CH(1)