OsteoporosisPhase 3NCT00433160

Phase 3 Clinical Trial of Teriparatide in Japan

A Phase 3 study testing Teriparatide in people with Osteoporosis, run by Eli Lilly and Company at 16 sites in Japan.

Completed

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

Trial summary

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Osteoporosis
What is being tested?: Teriparatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 207 participants
Where: 16 sitesJapan
Study dates: Jan 2007to Sep 2009
Phase: Phase 3
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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese patients diagnosed with osteoporosis
Aged 55 or older
Patients who are at high risk for fracture

Who cannot join

History of metabolic bone disorders other than primary osteoporosis
History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
Severe or chronically disabling conditions other than osteoporosis

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Japan16 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.
Aichi, 454-0933
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.
Fukuoka, 811-2101
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.
Hokkaido, 070-0034
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Hyōgo, 655-0853
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Kagoshima, 890-0014
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Kanagawa, 231-0023
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Nagano, 386-0493
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Nagasaki, 854-0083
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.
Numakunai, 020-8505
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.
Ōita, 879-7125
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.
Osaka, 555-0032
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.
Saitama, 358-0007
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.
Shimane, 693-0021
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.
Tokushima, 770-8503
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.
Tokyo, 163-0202
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.
Tottori, 683-0853

Other trials in Japan

About this study

Official title: Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Conditions: Osteoporosis
Being tested: Teriparatide, Placebo
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 LY333334, Forteo, Forsteo
daily, subcutaneous
PlaceboDrug
daily, subcutaneous

Study groups in NCT00433160
Study group	Role	What they receive
Teriparatide	Experimental	20 micrograms for 104 weeks Receives: Drug: Teriparatide
Placebo	Placebo comparator	Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks Receives: Drug: Teriparatide; Drug: Placebo

What is being measured

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

Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Measured: Baseline to 52 weeks

Secondary outcomes (19)

Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Measured: Baseline to 52 Weeks
Percent Change in Bone Mineral Density (BMD) at Total Hip
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Measured: Baseline to 52 Weeks
Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Measured: Baseline to 52 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Measured: Baseline to Weeks 4, 12, 24, and 52
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Measured: Baseline to Weeks 4, 12, 24, 52
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
Measured: Baseline to Weeks 4, 12, 24, 52
Vertebral Fractures by Central X-ray Assessment
Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Measured: Baseline through 52 weeks
Fractures by Investigators Assessment
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Measured: Baseline through 52 Weeks
Back Pain Severity
Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).
Measured: Baseline, Weeks 12, 24, 36, 52
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Measured: Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Measured: Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Measured: Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Measured: Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Measured: Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Measured: Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
Measured: Baseline, 76 Weeks, 104 Weeks
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Measured: Baseline through 104 Weeks
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Measured: Baseline Through 104 Weeks
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).
Measured: Baseline, 76 Weeks, 104 Weeks

Timeline

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

Jan 2007Sep 2009

First posted9 Feb 2007 (estimated)
Study startJan 2007
Primary completionSep 2008
Study completionSep 2009

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.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00433160
Sponsor's protocol ID: 10494
Other IDs: B3D-JE-GHDB
Status last verified: Sep 2010
First submitted: 7 Feb 2007
Last updated: 21 Sep 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.
PubMed 20580870
Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.
PubMed 26185429

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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Vertebra Compression Fracture
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The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis
ClinicalTrials.gov ID: NCT00433160
Acronym / sponsor ID: 10494
Conditions: Osteoporosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2009 (actual)
First posted: 9 Feb 2007 (estimated)
Results: Posted 30 Sep 2009

Clinical summary

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

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

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: Teriparatide20 micrograms for 104 weeks
Placebo	Placebo comparator	Drug: Teriparatide, Drug: PlaceboPlacebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Japanese patients diagnosed with osteoporosis
Aged 55 or older
Patients who are at high risk for fracture

Key exclusion criteria (3 listed)

History of metabolic bone disorders other than primary osteoporosis
History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
Severe or chronically disabling conditions other than osteoporosis

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: LY333334, Forteo, Forsteodaily, subcutaneous	Drug	Placebo, Teriparatide
Placebodaily, subcutaneous	Drug	Placebo

Primary outcome

Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Time frame: Baseline to 52 weeks
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.

19 secondary outcomes

Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Time frame: Baseline to 52 Weeks
Percent Change in Bone Mineral Density (BMD) at Total Hip
Time frame: Baseline to 52 Weeks
Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Time frame: Baseline to 52 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Time frame: Baseline to Weeks 4, 12, 24, and 52
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Time frame: Baseline to Weeks 4, 12, 24, 52
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Time frame: Baseline to Weeks 4, 12, 24, 52
Vertebral Fractures by Central X-ray Assessment
Time frame: Baseline through 52 weeks
Fractures by Investigators Assessment
Time frame: Baseline through 52 Weeks
Back Pain Severity
Time frame: Baseline, Weeks 12, 24, 36, 52
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Time frame: Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Time frame: Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Time frame: Baseline, 76 Weeks, 104 Weeks
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Time frame: Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
Time frame: Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Time frame: Baseline, 76 Weeks, 104 Weeks
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
Time frame: Baseline, 76 Weeks, 104 Weeks
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
Time frame: Baseline through 104 Weeks
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Time frame: Baseline Through 104 Weeks
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Time frame: Baseline, 76 Weeks, 104 Weeks

Results and safety

Results posted to the registry on 30 Sep 2009, 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	137	120
Placebo	70	60

Primary outcome: Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)

Time frame: Baseline to 52 weeks. Mean (Standard Deviation). Unit: percent change in BMD

Measure	Teriparatide n = 131	Placebo n = 63
Percent Change to Last Measurement Point	9.82 (5.36)	0.04 (4.34)

Teriparatide vs Placebo: p <0.001, t-test, 2 sided

Population analysed: Number of randomized participants with at least one dose of study drug and at least one post-treatment measurement.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events and Other Adverse Events are reported for both treatment arms for the following time frames: double-blind treatment (During 52 weeks); open-label treatment (During 76 weeks); open-label treatment (During 104 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teriparatide (During 52 Weeks)	7 of 136 (5.1%)	115 of 136 (84.6%)	Not reported
Placebo (During 52 Weeks)	7 of 67 (10.4%)	59 of 67 (88.1%)	Not reported
Teriparatide (During 76 Weeks)	10 of 136 (7.4%)	123 of 136 (90.4%)	Not reported
Placebo (During 76 Weeks)	9 of 67 (13.4%)	60 of 67 (89.6%)	Not reported
Teriparatide (During 104 Weeks)	12 of 136 (8.8%)	125 of 136 (91.9%)	Not reported
Placebo (During 104 Weeks)	13 of 67 (19.4%)	64 of 67 (95.5%)	Not reported

Limitations and caveats (from the sponsor): Original data presented were for the 52-week double-blinded treatment phase; results of the open label phases at 76 weeks and 104 weeks have now been added

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20580870Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.
Derived from this study: PubMed 26185429Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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
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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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teriparatide in people with Osteoporosis, run by Eli Lilly and Company at 16 sites in Japan.

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 3 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 21 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Sep 2009). 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?

Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) (time frame: Baseline to 52 weeks). 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 NCT00433160, which also lists 2 linked publications.

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 21 Sep 2010.