OsteoporosisPhase 2NCT00752557

Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD

A Phase 2 study testing rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) and bisphosphonates, calcium, and vitamin D in people with Osteoporosis, run by Pfizer at 35 sites in 4 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 to 85 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy) and bisphosphonates, calcium, and vitamin D
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 35 sitesin 4 countries
Study dates: 3 Dec 2008to 24 Apr 2015
Phase: Phase 2
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 65 to 85 years
Women only
No healthy volunteers
Older adult

Who may be able to join

Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years.
BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present:
Age greater than 75 years
Family (maternal) history of fragility fracture
Previous fragility fracture (self) after age 45
Subjects may either be treatment naïve or on a previously-established regimen ( greater than 1year, but less than 5 years duration) of bisphosphonate therapy. Subjects must be willing to comply with 1of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy.

Who cannot join

Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Paget's disease, vitamin D deficiency [ less than 20 ng/mL], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia).
Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months.
Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.

Trial locations and contacts

35 sites in 4 countries.

Country

City, postcode or hospital

35 sites in 4 countries

United States28 sites

University Orthopedics Center
Altoona, Pennsylvania, 16602
Florida Hospital Deland
DeLand, Florida, 32720
Florida Orthopaedic Associates, P.A.
DeLand, Florida, 32720
Florida Research Associates, LLC
DeLand, Florida, 32720
Victoria Park Imaging
DeLand, Florida, 32724
Duke University Medical Center
Durham, North Carolina, 27710
Diagnostic Professionals, Inc.
Fort Lauderdale, Florida, 33311
Shrock Orthopedic Research
Fort Lauderdale, Florida, 33316
Cool Spring Interventional, PLLC
Franklin, Tennessee, 37067
Center for Women's Health Research at Meharry Medical College
Nashville, Tennessee, 37208-3599
Suncoast Clinical Research Inc
New Port Richey, Florida, 34652
Coastal orthopedic and Sports Medicine
New Port Richey, Florida, 34653
Columbia University Medical Center
New York, New York, 10032
Creighton University Medical Center
Omaha, Nebraska, 68131
Creighton University Osteoporosis Research Center
Omaha, Nebraska, 68131
Arizona Research Center, Inc.
Phoenix, Arizona, 85023
John C. Lincoln Hospital - Deer Valley
Phoenix, Arizona, 85027
Westside Regional Medical Center
Plantation, Florida, 33324
Florida Arthritis & Osteoporosis Center
Port Richey, Florida, 34668
UC Davis Medical Center
Sacramento, California, 95817
Intensive Research Unit
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Center for Advanced Medicine
St Louis, Missouri, 63310
University Orthopedics Center
State College, Pennsylvania, 16801
Medical Center of Trinity
Trinity, Florida, 34655
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Prairie Lakes Healthcare Systems
Watertown, South Dakota, 57201G
Brown Clinic
Watertown, South Dakota, 57201

Other trials in United States

Poland3 sites

Synexus Polska Sp. z o.o.
Warsaw, Masovian Voivodeship, 01-192
Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej
Warsaw, Masovian Voivodeship, 01-258
Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej
Warsaw, Masovian Voivodeship, 02-507

Other trials in Poland

Belgium2 sites

Universitair Ziekenhuis Gent
Ghent, 9000
Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont
Waterschei (Genk), 3600

Other trials in Belgium

Spain2 sites

Clinica Ruber
Madrid, 28006
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, 28009

Other trials in Spain

About this study

Official title: A PHASE 2, MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM PHOSPHATE MATRIX(CPM) IN SUBJECTS WITH DECREASED BONE MINERAL DENSITY

The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip. All subjects will receive standard treatment for low bone mass, consisting of bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly selected to receive treatment with rhBMP-2 will receive an injection directly into the hip. The injection is given in a surgery room using a light anesthesia.

Conditions: Osteoporosis
Being tested: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy), bisphosphonates, calcium, and vitamin D
Keywords: Bone mineral density, bone morphogenetic protein, osteoporosis
Medical subject headings: Osteoporosis

What participants receive

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

rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)Drug
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)Drug
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.
bisphosphonates, calcium, and vitamin DDrug
Oral bisphosphonate therapy

Study groups in NCT00752557
Study group	Role	What they receive
1	Experimental	rhBMP-2/CPM , 1.0 mg/mL Receives: Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
2	Experimental	rhBMP-2/CPM , 2.0 mg/mL Receives: Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
3	Active comparator	Oral bisphosphonate therapy (standard of care) Receives: Drug: bisphosphonates, calcium, and vitamin D

What is being measured

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

Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.
Measured: Baseline, 12 months post dose
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip
Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]).
Measured: At Month 12
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.
Measured: At Month 12

Secondary outcomes (4)

Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs.
Measured: 24 months
Number Participant Responses to Injectability Questionnaire Injected Population
Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered.
Measured: Participants were monitored after treatment administration (dosing period)
Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator.
Measured: Baseline up to 12 months
Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below.
Measured: 36 months

Timeline

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

3 Dec 200824 Apr 2015

First posted15 Sep 2008 (estimated)
Study start3 Dec 2008
Primary completion24 Apr 2015
Study completion24 Apr 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 PfizerThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00752557
Sponsor's protocol ID: 3100N0-2213
Other IDs: B1921002, 2007-007456-34
Status last verified: Mar 2020
First submitted: 12 Sep 2008
Last updated: 20 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 2, MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM PHOSPHATE MATRIX(CPM) IN SUBJECTS WITH DECREASED BONE MINERAL DENSITY
ClinicalTrials.gov ID: NCT00752557
Acronym / sponsor ID: 3100N0-2213
Conditions: Osteoporosis
Keywords: Bone mineral density, bone morphogenetic protein, osteoporosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 3 Dec 2008 (actual)
Primary completion: 24 Apr 2015 (actual)
Study completion: 24 Apr 2015 (actual)
First posted: 15 Sep 2008 (estimated)
Results: Posted 20 Mar 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)rhBMP-2/CPM , 1.0 mg/mL
2	Experimental	Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)rhBMP-2/CPM , 2.0 mg/mL
3	Active comparator	Drug: bisphosphonates, calcium, and vitamin DOral bisphosphonate therapy (standard of care)

Who may qualify

Ages: 65 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years.
BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present:
Age greater than 75 years
Family (maternal) history of fragility fracture
Previous fragility fracture (self) after age 45

Key exclusion criteria (3 listed)

Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Paget's disease, vitamin D deficiency [ less than 20 ng/mL], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia).
Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months.
Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.

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
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.	Drug	1
rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.	Drug	2
bisphosphonates, calcium, and vitamin DOral bisphosphonate therapy	Drug	3

Primary outcome

Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)
Time frame: Baseline, 12 months post dose
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip
Time frame: At Month 12
Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix [CPM]).
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck
Time frame: At Month 12
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.

4 secondary outcomes

Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
Time frame: 24 months
Number Participant Responses to Injectability Questionnaire Injected Population
Time frame: Participants were monitored after treatment administration (dosing period)
Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
Time frame: Baseline up to 12 months
Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip
Time frame: 36 months

Results and safety

Results posted to the registry on 20 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care Control	17	12
rhBMP-2/CPM 1.0 mg/mL	16	11
rhBMP-2/CPM 2.0mg/mL	17	11

Primary outcome: Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)

Time frame: Baseline, 12 months post dose. Mean (Standard Deviation). Unit: gram per centimeter squared (g/cm^2)

Measure	Standard of Care Control n = 14	rhBMP-2/CPM 1.0 mg/mL n = 12	rhBMP-2/CPm 2.0 mg/mL n = 14
Total hip	-0.0026 (0.018)	0.1299 (0.045)	0.1196 (0.063)
Intertrochanter	-0.0029 (0.020)	0.1063 (0.066)	0.1192 (0.063)
Trochanter	-0.0091 (0.023)	0.1197 (0.066)	0.0869 (0.073)
Femoral neck	0.0058 (0.021)	0.2408 (0.111)	0.2120 (0.117)

Population analysed: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.

Primary outcome: Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip

Time frame: At Month 12. Mean (Standard Deviation). Unit: milligram per centimeter cubed (mg/cm^3)

Measure	Standard of Care Control n = 13	rhBMP-2/CPM 1.0 mg/mL n = 11	rhBMP-2/CPm 2.0 mg/mL n = 14
Cortical + Sub-Cortical	136.8 (16.91)	165.6 (18.37)	151.6 (26.07)
Peeled Trabecular	45.1 (16.02)	77.8 (23.07)	88.4 (37.63)
Integral	181.9 (20.60)	243.4 (31.04)	240.0 (45.31)

Primary outcome: Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck

Time frame: At Month 12. Mean (Standard Deviation). Unit: mg/cm^3

Measure	Standard of Care Control n = 13	rhBMP-2/CPM 1.0 mg/mL n = 11	rhBMP-2/CPm 2.0 mg/mL n = 14
Cortical +Sub Cortical	144.3 (16.81)	166.3 (31.06)	164.4 (29.37)
Peeled Trabecular	61.1 (14.39)	165.0 (59.13)	159.3 (38.97)
Integral	205.4 (23.02)	331.3 (73.99)	323.7 (58.96)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care Control	3 of 17 (17.6%)	13 of 17 (76.5%)	Not reported
rhBMP-2/CPM 1.0 mg/mL	7 of 15 (46.7%)	15 of 15 (100%)	Not reported
rhBMP-2/CPm 2.0 mg/mL	7 of 14 (50%)	12 of 14 (85.7%)	Not reported

Limitations and caveats (from the sponsor): 46 participants enrolled; further enrollment suspended due to safety signal. Participants completed long-term follow up per protocol; extra 2 years per protocol amendment. Sample size small to draw conclusions, to conduct efficacy interim analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

35 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Poland, Belgium, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 20 Mar 2020). 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 From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) (time frame: Baseline, 12 months post dose). The study lists 3 primary outcomes in all. 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 NCT00752557.

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 20 Mar 2020.