A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture (MOVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00887354
First received: April 23, 2009
Last updated: April 1, 2014
Last verified: April 2014

April 23, 2009
April 1, 2014
April 2009
August 2015   (final data collection date for primary outcome measure)
Change in Lumbar Spine Areal Bone Mineral Density [ Time Frame: Baseline, 18 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00887354 on ClinicalTrials.gov Archive Site
  • Change in Lumbar Spine Areal Bone Mineral Density [ Time Frame: Baseline, 26 Weeks, 12 Months ] [ Designated as safety issue: No ]
  • Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb [ Time Frame: Baseline, 26 Weeks, 12 Months, 18 Months ] [ Designated as safety issue: No ]
  • Short form-36 (SF-36) Questionnaire [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks of Treatment ] [ Designated as safety issue: No ]
  • Modification of the Charnley's Pain Scale [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ] [ Designated as safety issue: No ]
  • Timed "Up and Go" Test [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ] [ Designated as safety issue: No ]
  • Visual Analog Scale [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture

This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.

The study has 3 periods: a screening phase, a double-blind, double-dummy treatment phase from the time of randomization to the 26 weeks visit, and an open-label treatment phase of approximately 12 month duration, where participants will continue treatment with the same study drug that they were randomized to.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis
  • Drug: Teriparatide
    Administered subcutaneously
    Other Names:
    • Forteo
    • Forsteo
    • LY333334
  • Drug: Risedronate
    Administered orally
  • Drug: Placebo

    Weekly: Administered orally

    Daily: Administered subcutaneously

  • Dietary Supplement: Calcium
    Approximately 500 to 1000 mg/day administered orally throughout study.
  • Dietary Supplement: Vitamin D
    Approximately 800 International Units per day (IU/day) administered orally throughout study.
  • Experimental: Teriparatide

    20 micrograms (mcg) a day by subcutaneous injection throughout study.

    Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only.

    Interventions:
    • Drug: Teriparatide
    • Drug: Placebo
    • Dietary Supplement: Calcium
    • Dietary Supplement: Vitamin D
  • Active Comparator: Risedronate

    35 milligrams (mg) risedronate sodium orally once weekly throughout study.

    Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only.

    Interventions:
    • Drug: Risedronate
    • Drug: Placebo
    • Dietary Supplement: Calcium
    • Dietary Supplement: Vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
242
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region
  • Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men

Exclusion Criteria:

  • Clinically significant abnormal laboratory values
  • History of unresolved skeletal diseases that affect bone metabolism
  • Polytrauma participants and participants with fractures at more than one site
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Croatia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Italy,   Mexico,   Norway,   Spain
 
NCT00887354
12400, B3D-EW-GHDK
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM eastern time (UTC/GMT-5hours, EST) Eli Lilly and Company
Eli Lilly and Company
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP