NCT01249261

Brief Summary

The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2001

Geographic Reach
8 countries

13 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

October 1, 2001

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 26, 2011

Completed
Last Updated

November 2, 2011

Status Verified

October 1, 2011

Enrollment Period

1.6 years

First QC Date

November 24, 2010

Results QC Date

July 14, 2011

Last Update Submit

October 27, 2011

Conditions

Postmenopausal Women With Osteoporosis

Keywords

Postmenopausal WomenOsteoporosis

Outcome Measures

Primary Outcomes (12)

  • Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population

    Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 6 (Year 8)

  • Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population

    Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 12 (Year 8)

  • Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population

    Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2\*BMD, Hologic sBMD = 1075.5\*BMD. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

  • Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population

    Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 6 (Year 8)

  • Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population

    Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 12 (Year 8)

  • Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population

    Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836\*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

  • Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population

    Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 6 (Year 8)

  • Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population

    Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 12 (Year 8)

  • Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population

    Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

  • Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population

    Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 6 (Year 8)

  • Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population

    Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 12 (Year 8)

  • Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population

    Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).

    Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)

Study Arms (2)

Placebo/Risedronate

PLACEBO COMPARATOR

Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8

Drug: Placebo/Risedronate

Risedronate

ACTIVE COMPARATOR

Risedronate 5mg years 1-7, no drug year 8

Drug: Risedronate

Interventions

RisedronateDRUG

5 mg/day

Risedronate
Placebo/RisedronateDRUG

placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8

Placebo/Risedronate

Eligibility Criteria

AgeUp to 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women who sequentially completed studies RVE009093, RVE1996077, RVE1998080

You may not qualify if:

  • Less than 60% compliant between drug start and month 21
  • Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection \>10,000 IU vitamin D, investigational drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Investigational Site

Concord, New South Wales, 2139, Australia

Location

Investigational Site

Parkville, Victoria, 3052, Australia

Location

Investigational Site

De Pintelaan 185, Gent, B-9000, Belgium

Location

Investigational Site

Hvidovre, Denmark, DK-2650, Denmark

Location

Investigational Site

Oulu, Finland, SF-90 100, Finland

Location

Investigational Site

Siena, Italy, I-53100, Italy

Location

Investigational Site

Warsaw, Poland, PL 03-0335, Poland

Location

Investigational Site

Warsaw, Poland, PL-02315, Poland

Location

Investigational Site

Warsaw, Poland, PL-04-736, Poland

Location

Investigational Site

Warsaw, Poland, PL00-909, Poland

Location

Investigational Site

Barcelona, Spain, 08907, Spain

Location

Investigational Site

Madrid, Spain, 28040, Spain

Location

Investigational Site

Gothenburg, Sweden, S-411 32, Sweden

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

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

Study Officials

  • Herman Ellman, MD

    Warner Chilcott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 29, 2010

Study Start

October 1, 2001

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

November 2, 2011

Results First Posted

October 26, 2011

Record last verified: 2011-10

Locations

BE(1)DK(1)AU(2)FI(1)IT(1)ES(2)SE(1)PL(4)