OsteoporosisPhase 3NCT03512262
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
A Phase 3 study testing Abaloparatide in people with Osteoporosis and Osteoporosis, Age-Related, run by Radius Health, Inc. at 34 sites in 3 countries.
Trial summary
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine
- What is being tested?
- Abaloparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 3 May 2018to 8 Sep 2021
- 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism.
- The participant has a BMD T-score based on female or male reference range (depending on date of enrollment) as assessed by the central imaging vendor of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA) or ≤ -1.5 and with radiologic evidence of vertebral fracture or a documented history of low-trauma nonvertebral fracture sustained in the past 5 years. Men older than 65 years may be enrolled if they have a BMD T-score ≤ -2.0 even if they do not meet the fracture criteria.
- Normal medical history, physical examination, including vital signs, and body mass index.
- Hypogonadal participants whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study.
- Laboratory tests within the normal range including serum calcium (albumin-corrected), parathyroid hormone, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone values.
Who cannot join
- Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal BMD, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
- A BMD T-score of ≤-3.5 at the total hip, femoral neck, or lumbar spine based on female or male reference range (depending on date of enrollment).
- Unevaluable hip BMD or participants who have undergone bilateral hip replacement.
- Fragility fracture within the prior twelve months.
- History of severe vertebral fracture or >2 moderate vertebral fractures.
- History of bone disorders (for example, Paget's disease) other than osteoporosis.
Show all 10Show fewer
- participant with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement.
- History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
- History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the participant.
- History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States22 sites
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106
University of Alabama at Birmingham
Birmingham, Alabama, 35294
PMG Research of Cary, LLC
Cary, North Carolina, 27518
Northwestern University
Chicago, Illinois, 60611
The University of Chicago
Chicago, Illinois, 60637
Ohio State University Medical Center
Columbus, Ohio, 43210
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Center For Advanced Research & Education
Gainesville, Georgia, 30501
Panorama Orthopedics & Spine Center
Golden, Colorado, 80401
Marin Endocrine Care & Research, Inc.
Greenbrae, California, 94904
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012
Centex Studies, Inc.
Houston, Texas, 77058
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, 53705
Centex Studies, Inc
McAllen, Texas, 78504
Baptist Diabetes Associates, Pa
Miami, Florida, 33156
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Meridian Clinical Research
Savannah, Georgia, 31406
Alta California Medical Group
Simi Valley, California, 93065
SUNY Upstate Medical University
Syracuse, New York, 13210
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia, 20007
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Poland9 sites
Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351
ClinicMed Daniluk, Nowak Sp.j.
Bialystok, 15-879
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-501
Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
Lodz, 90-558
ETG Siedlce
Siedlce, 08-110
Lubelskie Centrum Diagnostyczne
Świdnik, 21-040
NZOZ Nasz Lekarz
Torun, 87100
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 01-192
Synexus Polska Sp z o.o Oddzial we Wroclawiu
Wroclaw, 50-381
Italy3 sites
Azienda ospedaliera universitaria Careggi
Florence, Tuscany, 50139
Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, Tuscany, 53100
Azienda ospedaliera universitaria integrata di verona(AOUI)
Verona, 37134
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
Read the detailed description
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide 80 micrograms (mcg) per day administered subcutaneously (SC) compared to placebo in men with osteoporosis. Efficacy was primarily assessed by the change in bone mineral density (BMD) over 12 months.
- Conditions
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis, Osteoporosis Senile, Osteoporosis of Vertebrae
- Being tested
- Abaloparatide, Placebo
- Keywords
- BA058, abaloparatide, abaloparatide-SC, osteoporosis, male osteoporosis, TYMLOS®, fracture, bone loss
- Medical subject headings
- Osteoporosis, Fractures, Bone, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbaloparatideDrug
Also called TYMLOS®, BA058, abaloparatide-SC
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
PlaceboDrug
Abaloparatide-matched placebo.
| Study group | Role | What they receive |
|---|---|---|
| Abaloparatide | Experimental | Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days. Receives: Drug: Abaloparatide |
| Placebo | Placebo comparator | Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
Measured: Baseline, Month 12
Secondary outcomes (14)
Percent Change From Baseline in Total Hip BMD at Month 12
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Measured: Baseline, Month 12
Percent Change From Baseline in Femoral Neck BMD at Month 12
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Measured: Baseline, Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
Measured: Baseline, Month 6
Percent Change in Total Hip BMD From Baseline at Month 6
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Measured: Baseline, Month 6
Percent Change From Baseline in Femoral Neck BMD at Month 6
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Measured: Baseline, Month 6
Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12
Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Measured: Baseline, Month 12
Percent Change From Baseline in Distal One-third Radius BMD at Month 12
Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Measured: Baseline, Month 12
Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12
Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.
Measured: Baseline, Month 12
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12
Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss).
Measured: Baseline, Month 12
Number of Participants With New Clinical Fractures
Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit).
Measured: Baseline through Month 12
Percent of Participants With Change in Disease Status
The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following:
- Lumbar spine > -2.5 and total hip BMD T-score > -2.5 and < -1.0
- Lumbar spine > -2.5 and < -1.0 and total hip BMD T-score > -2.5
- Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0.
Measured: Baseline through Month 12
Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip
Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory.
Measured: Month 12
Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12
QCT scans were evaluated by a central imaging laboratory.
Measured: Baseline, Month 12
Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12
QCT scans were evaluated by a central imaging laboratory.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start3 May 2018
- Primary completion17 Aug 2021
- Study completion8 Sep 2021
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 (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomized in a 2:1 treatment ratio (abaloparatide:placebo).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radius Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512262
- Sponsor's protocol ID
- BA058-05-019
- Other IDs
- ATOM
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2018
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rizzoli R, Bonjour JP, Ferrari SL. Osteoporosis, genetics and hormones. J Mol Endocrinol. 2001 Apr;26(2):79-94. doi: 10.1677/jme.0.0260079.
PubMed 11241160Mannstadt M, Juppner H, Gardella TJ. Receptors for PTH and PTHrP: their biological importance and functional properties. Am J Physiol. 1999 Nov;277(5):F665-75. doi: 10.1152/ajprenal.1999.277.5.F665.
PubMed 10564229Dempster DW, Cosman F, Parisien M, Shen V, Lindsay R. Anabolic actions of parathyroid hormone on bone. Endocr Rev. 1993 Dec;14(6):690-709. doi: 10.1210/edrv-14-6-690. No abstract available.
PubMed 8119233Deal C, Bostrom MP, Sheth NP, Humbert L, Krohn KD, Wang Y, Boxberger JI. The effects of abaloparatide on acetabular bone mineral density and proximal femur strength in men with osteoporosis. J Clin Densitom. 2026 Apr-Jun;29(2):101686. doi: 10.1016/j.jocd.2026.101686. Epub 2026 Feb 17.
PubMed 41812602
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis
- ClinicalTrials.gov ID
- NCT03512262
- Acronym / sponsor ID
- BA058-05-019
- Conditions
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis, Osteoporosis Senile, Osteoporosis of Vertebrae
- Keywords
- BA058, abaloparatide, abaloparatide-SC, osteoporosis, male osteoporosis, TYMLOS®, fracture, bone loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Radius Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 May 2018 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
Detailed description
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide 80 micrograms (mcg) per day administered subcutaneously (SC) compared to placebo in men with osteoporosis. Efficacy was primarily assessed by the change in bone mineral density (BMD) over 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 2:1 treatment ratio (abaloparatide:placebo).
| Arm | Type | Receives |
|---|---|---|
| Abaloparatide | Experimental | Drug: AbaloparatideParticipants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism.
- The participant has a BMD T-score based on female or male reference range (depending on date of enrollment) as assessed by the central imaging vendor of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA) or ≤ -1.5 and with radiologic evidence of vertebral fracture or a documented history of low-trauma nonvertebral fracture sustained in the past 5 years. Men older than 65 years may be enrolled if they have a BMD T-score ≤ -2.0 even if they do not meet the fracture criteria.
- Normal medical history, physical examination, including vital signs, and body mass index.
- Hypogonadal participants whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study.
- Laboratory tests within the normal range including serum calcium (albumin-corrected), parathyroid hormone, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone values.
Key exclusion criteria (10 listed)
- Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal BMD, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
- A BMD T-score of ≤-3.5 at the total hip, femoral neck, or lumbar spine based on female or male reference range (depending on date of enrollment).
- Unevaluable hip BMD or participants who have undergone bilateral hip replacement.
- Fragility fracture within the prior twelve months.
- History of severe vertebral fracture or >2 moderate vertebral fractures.
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 |
|---|---|---|
| AbaloparatideAlso: TYMLOS®, BA058, abaloparatide-SCAbaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway. | Drug | Abaloparatide |
| PlaceboAbaloparatide-matched placebo. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Time frame: Baseline, Month 12
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
14 secondary outcomes
Percent Change From Baseline in Total Hip BMD at Month 12
Time frame: Baseline, Month 12
Percent Change From Baseline in Femoral Neck BMD at Month 12
Time frame: Baseline, Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Time frame: Baseline, Month 6
Percent Change in Total Hip BMD From Baseline at Month 6
Time frame: Baseline, Month 6
Percent Change From Baseline in Femoral Neck BMD at Month 6
Time frame: Baseline, Month 6
Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12
Time frame: Baseline, Month 12
Percent Change From Baseline in Distal One-third Radius BMD at Month 12
Time frame: Baseline, Month 12
Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12
Time frame: Baseline, Month 12
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12
Time frame: Baseline, Month 12
Number of Participants With New Clinical Fractures
Time frame: Baseline through Month 12
Percent of Participants With Change in Disease Status
Time frame: Baseline through Month 12
Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip
Time frame: Month 12
Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12
Time frame: Baseline, Month 12
Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11241160Rizzoli R, Bonjour JP, Ferrari SL. Osteoporosis, genetics and hormones. J Mol Endocrinol. 2001 Apr;26(2):79-94. doi: 10.1677/jme.0.0260079.
- Background: PubMed 10564229Mannstadt M, Juppner H, Gardella TJ. Receptors for PTH and PTHrP: their biological importance and functional properties. Am J Physiol. 1999 Nov;277(5):F665-75. doi: 10.1152/ajprenal.1999.277.5.F665.
- Background: PubMed 8119233Dempster DW, Cosman F, Parisien M, Shen V, Lindsay R. Anabolic actions of parathyroid hormone on bone. Endocr Rev. 1993 Dec;14(6):690-709. doi: 10.1210/edrv-14-6-690. No abstract available.
- Derived from this study: PubMed 41812602Deal C, Bostrom MP, Sheth NP, Humbert L, Krohn KD, Wang Y, Boxberger JI. The effects of abaloparatide on acetabular bone mineral density and proximal femur strength in men with osteoporosis. J Clin Densitom. 2026 Apr-Jun;29(2):101686. doi: 10.1016/j.jocd.2026.101686. Epub 2026 Feb 17.
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.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abaloparatide in people with Osteoporosis and Osteoporosis, Age-Related, run by Radius Health, Inc. at 34 sites in 3 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 5 inclusion and 10 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Poland, Italy. 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 7 Apr 2023). 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 From Baseline in Lumbar Spine BMD at Month 12 (time frame: Baseline, Month 12). 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 NCT03512262, which also lists 4 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 7 Apr 2023.