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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00887354
First received: April 23, 2009
Last updated: January 27, 2017
Last verified: January 2017
April 23, 2009
January 27, 2017
April 2009
August 2015   (Final data collection date for primary outcome measure)
Change in Lumbar Spine Areal Bone Mineral Density (BMD) [ Time Frame: Baseline, Week 78 ]
Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
Change in Lumbar Spine Areal Bone Mineral Density [ Time Frame: Baseline, 18 Months ]
Complete list of historical versions of study NCT00887354 on ClinicalTrials.gov Archive Site
  • Change in Lumbar Spine Areal Bone Mineral Density [ Time Frame: Baseline, Week 26; Baseline, Week 52 ]
    Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
  • Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb [ Time Frame: Baseline, Week 26; Baseline, Week 52; Baseline, Week 78 ]

    Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .

    Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use.

  • Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire [ Time Frame: Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26 ]
    SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).
  • Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale [ Time Frame: Baseline ]
    Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.
  • Visual Analog Scale (VAS) [ Time Frame: 6, 12, 18, and 26 Weeks ]
    Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.
  • Timed "Up and Go" Test [ Time Frame: 6, 12, 18, and 26 Weeks ]
    Timed "Up and Go" test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score.
  • Change in Lumbar Spine Areal Bone Mineral Density [ Time Frame: Baseline, 26 Weeks, 12 Months ]
  • 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 ]
  • Short form-36 (SF-36) Questionnaire [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks of Treatment ]
  • Modification of the Charnley's Pain Scale [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ]
  • Timed "Up and Go" Test [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ]
  • Visual Analog Scale [ Time Frame: Baseline, 6, 12, 18, and 26 Weeks ]
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Osteoporosis
  • Drug: Teriparatide
    Administered subcutaneously
    Other Names:
    • Forteo
    • 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.
 
Completed
224
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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Croatia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Italy,   Mexico,   Norway,   Spain,   United States
Austria,   Finland,   Ireland,   Puerto Rico,   Sweden,   United Kingdom
 
NCT00887354
12400
B3D-EW-GHDK ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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
January 2017

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