OsteoporosisPhase 4MOVENCT00887354

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

A Phase 4 study testing Teriparatide, Risedronate and Calcium in people with Osteoporosis, run by Eli Lilly and Company at 28 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Osteoporosis
What is being tested?: Teriparatide, Risedronate and Calcium
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 224 participants
Where: 28 sitesin 12 countries
Study dates: Apr 2009to Aug 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

28 sites in 12 countries.

Country

City, postcode or hospital

28 sites in 12 countries

United States6 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Durham, North Carolina, 27710
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Fargo, North Dakota, 58103
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Fort Lauderdale, Florida, 33316
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New Port Richey, Florida, 34652
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New York, New York, 10075
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Orlando, Florida, 32804

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Spain5 sites

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Barcelona, 08025
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Girona, 17007
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Madrid, 28041
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Marbella, 29600
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Seville, 41013

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France4 sites

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Orléans, 45032
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Paris, 75679
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Saint-Etienne, 42055
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Villeurbanne, 69100

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Czechia2 sites

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Klatovy, 33938
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Prague, 140 59

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Denmark2 sites

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Odense, 5000
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Viborg, 8800

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Italy2 sites

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Milan, 20122
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Rome, 00133

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Mexico2 sites

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Mexicali, 21200
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Monterrey, 64460

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Canada1 site

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Toronto, Ontario, M5G 2C4

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Croatia1 site

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Zagreb, 10000

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Germany1 site

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Göttingen, 37075

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Greece1 site

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Thessaloniki, 56429

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Norway1 site

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Oslo, 0407

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About this study

Official title: 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

Read the detailed description

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.

Conditions: Osteoporosis
Being tested: Teriparatide, Risedronate, Placebo, Calcium, Vitamin D
Keywords: Low bone mass, Recent pertrochanteric hip fracture
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TeriparatideDrug
Also called Forteo, LY333334
Administered subcutaneously
RisedronateDrug
Administered orally
PlaceboDrug
Weekly: Administered orally
Daily: Administered subcutaneously
CalciumDietary supplement
Approximately 500 to 1000 mg/day administered orally throughout study.
Vitamin DDietary supplement
Approximately 800 International Units per day (IU/day) administered orally throughout study.

Study groups in NCT00887354
Study group	Role	What they receive
Teriparatide	Experimental	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. Receives: Drug: Teriparatide; Drug: Placebo; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D
Risedronate	Active comparator	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. Receives: Drug: Risedronate; Drug: Placebo; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Lumbar Spine Areal Bone Mineral Density (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 lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
Measured: Baseline, Week 78

Secondary outcomes (6)

Change in Lumbar Spine Areal Bone Mineral Density
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).
Measured: Baseline, Week 26; Baseline, Week 52
Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
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.
Measured: Baseline, Week 26; Baseline, Week 52; Baseline, Week 78
Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire
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).
Measured: Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
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.
Measured: Baseline
Visual Analog Scale (VAS)
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.
Measured: 6, 12, 18, and 26 Weeks
Timed "Up and Go" Test
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.
Measured: 6, 12, 18, and 26 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Aug 2015

First posted24 Apr 2009 (estimated)
Study startApr 2009
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00887354
Sponsor's protocol ID: 12400
Other IDs: B3D-EW-GHDK
Acronym: MOVE
Status last verified: Sep 2019
First submitted: 23 Apr 2009
Last updated: 25 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00887354
Acronym / sponsor ID: MOVE / 12400
Conditions: Osteoporosis
Keywords: Low bone mass, Recent pertrochanteric hip fracture
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 24 Apr 2009 (estimated)
Results: Posted 9 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Teriparatide	Experimental	Drug: Teriparatide, Drug: Placebo, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D20 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.
Risedronate	Active comparator	Drug: Risedronate, Drug: Placebo, Dietary Supplement: Calcium, Dietary Supplement: Vitamin D35 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TeriparatideAlso: Forteo, LY333334Administered subcutaneously	Drug	Teriparatide
RisedronateAdministered orally	Drug	Risedronate
PlaceboWeekly: Administered orally Daily: Administered subcutaneously	Drug	Risedronate, Teriparatide
CalciumApproximately 500 to 1000 mg/day administered orally throughout study.	Dietary supplement	Risedronate, Teriparatide
Vitamin DApproximately 800 International Units per day (IU/day) administered orally throughout study.	Dietary supplement	Risedronate, Teriparatide

Primary outcome

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).

6 secondary outcomes

Change in Lumbar Spine Areal Bone Mineral Density
Time frame: Baseline, Week 26; Baseline, Week 52
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
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
Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
Time frame: Baseline
Visual Analog Scale (VAS)
Time frame: 6, 12, 18, and 26 Weeks
Timed "Up and Go" Test
Time frame: 6, 12, 18, and 26 Weeks

Results and safety

Results posted to the registry on 9 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teriparatide	111	60
Risedronate	113	65

Primary outcome: Change in Lumbar Spine Areal Bone Mineral Density (BMD)

Time frame: Baseline, Week 78. Least squares mean (Standard Error). Unit: gram per square centimeter (g/cm^2)

Measure	Teriparatide n = 61	Risedronate n = 66
Value	0.094 (0.0075)	0.055 (0.0081)

Teriparatide vs Risedronate: LS Mean: 0.040 (95% CI 0.025 to 0.055), p <.0001, Mixed Models Analysis

Population analysed: All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teriparatide	21 of 106 (19.8%)	53 of 106 (50%)	Not reported
Risedronate	27 of 110 (24.5%)	47 of 110 (42.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
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Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM eastern time (UTC/GMT-5hours, EST) study director

Eli Lilly and Company

28 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Teriparatide, Risedronate and Calcium in people with Osteoporosis, run by Eli Lilly and Company at 28 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Spain, France, Czechia, Denmark and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lumbar Spine Areal Bone Mineral Density (BMD) (time frame: Baseline, Week 78). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00887354.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.