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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Short name MOVE

NCTNCT00887354 (opens ClinicalTrials.gov in a new tab)Other id12400Other idB3D-EW-GHDK
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
224 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Quadruple masking
Countries
12 countries

United States, Canada, Croatia, Czechia, Denmark, France, Germany, Greece, Italy, Mexico, Norway, Spain

Start
Apr 2009
Primary completion
Aug 2015
Completion
Aug 2015
First posted
24 Apr 2009 (estimated)
Last update posted
25 Sept 2019
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201220142016
  1. Ph 4

    MOVE

    NCT00887354

    Apr 2009 to Aug 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug
  • RisedronateDrug
  • PlaceboDrug
  • CalciumDietary supplement
  • Vitamin DDietary supplement

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Lumbar Spine Areal Bone Mineral Density (BMD)

    Time frame · Baseline, Week 78

    Registry description

    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).

Secondary outcomes(6)

  1. Change in Lumbar Spine Areal Bone Mineral Density

    Time frame · Baseline, Week 26; Baseline, Week 52

    Registry description

    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).

  2. 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

    Registry description

    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.

  3. 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

    Registry description

    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).

  4. Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale

    Time frame · Baseline

    Registry description

    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.

  5. Visual Analog Scale (VAS)

    Time frame · 6, 12, 18, and 26 Weeks

    Registry description

    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.

  6. Timed "Up and Go" Test

    Time frame · 6, 12, 18, and 26 Weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 78

Change in Lumbar Spine Areal Bone Mineral Density (BMD)

GroupValue (gram per square centimeter (g/cm^2))Spread
Teriparatide0.0940.0075
Risedronate0.0550.0081
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Baseline, Week 26; Baseline, Week 52

Change in Lumbar Spine Areal Bone Mineral Density

GroupValue (g/cm^2)Spread
Teriparatide0.0530.0074
Risedronate0.0320.0081
Secondary outcomeLeast squares mean· Baseline, Week 26; Baseline, Week 52; Baseline, Week 78

Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb

GroupValue (g/cm^2)Spread
Teriparatide-0.0010.0042
Risedronate-0.0010.0042
Secondary outcomeLeast squares mean· Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26

Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire

GroupValue (units on a scale)Spread
Teriparatide7.371.065
Risedronate5.101.087
Secondary outcomeNumber· Baseline

Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale

GroupValue (percentage of participants)
Teriparatide9.4
Risedronate8.2
Secondary outcomeLeast squares mean· 6, 12, 18, and 26 Weeks

Visual Analog Scale (VAS)

GroupValue (millimeter (mm))Spread
Teriparatide16.443.977
Risedronate23.544.443
Secondary outcomeLeast squares mean· 6, 12, 18, and 26 Weeks

Timed "Up and Go" Test

GroupValue (seconds (sec))Spread
Teriparatide26.451.090
Risedronate32.381.085

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teriparatide20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.–21 / 10653 / 106
Risedronate35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.–27 / 11047 / 110

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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