Osteogenesis ImperfectaPhase 3OINCT02352753
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
A Phase 3 study testing Denosumab in people with Osteogenesis Imperfecta, run by Amgen at 49 sites in 13 countries.
Trial summary
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 49 sitesin 13 countries
- Study dates
- 24 Jun 2015to 26 Mar 2022
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI Clinical severity of OI as defined by 2 or more prevalent vertebral compression fractures; OR1 prevalent vertebral compression fracture and 1 or more nonvertebral fractures within the previous 2 years; OR 3 or more fractures within the previous 2 years.
Who cannot join
- Inability or unwillingness to comply with the requirements for frequent calcium and phosphorus monitoring for 14 days after the first dose of denosumab (only applies to the first 5 subjects age 11 to17 enrolled in the study and the first 5 subjects of any age meeting the criteria for increased bone turnover
- Currently unhealed fracture or osteotomy as defined by orthopedic opinion
- Osteotomy within 5 months of screening
- Evidence of untreated oral cavities or oral infections
- Recent or planned invasive dental procedure
- Surgical tooth extraction which has not healed by screening
Show all 36Show fewer
- History of an electrophoresis pattern inconsistent with type I to IV OI
- History of genetic testing results inconsistent with type I to IV OI
- Abnormalities of the following per central laboratory reference ranges at screening: Serum albumin corrected calcium < lower limit of normal (LLN) Serum vitamin D < 20 ng/mL; re-screening for Vitamin D level < 20 ng/mL will be allowed, after adequate supplementation
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN)
- Total bilirubin (TBL) > 1.5 x ULN (subjects with Gilbert syndrome are eligible)
- Serum phosphorus < LLN
- Serum alkaline phosphatase > 20% above the ULN or > 20% below the LLN
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (calculated bythe Schwartz equation at screening) Evidence of any of the following: Current hyperthyroidism (unless well-controlled on stable antithyroid therapy)
- Current clinical hypothyroidism (unless well-controlled on stable thyroid replacement therapy)
- History of hyperparathyroidism
- Current hypoparathyroidism
- Current, uncontrolled hypercalcemia (albumin-corrected serum Ca >10% ULN)
- History of osteomalacia or rickets (chart review)
- Other bone diseases that affect bone metabolism (eg, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis, hypophosphatasia)
- History of autoimmune disease
- History of rare hereditary problems of fructose intolerance
- Positive blood screen for human immunodeficiency virus -1 or -2 antibody
- Positive blood screen for hepatitis B surface antigen or hepatitis C antibody
- Received other osteoporosis treatment or bone active treatment with the following guidelines:
- Prior treatment with
- denosumab
- fluoride or strontium for bone disease (fluoride taken for routine dental care is permitted)
- parathyroid hormone (PTH) or PTH derivatives within 12 months prior to screening
- zoledronic acid within 6 months prior to screening
- oral bisphosphonates or intravenous bisphosphonates other than zoledronic acid if the first dose of denosumab would be before their next scheduled bisphosphonate dose would have been given
- Administration of systemic glucocorticoids (≥ 5.0 mg prednisone equivalents/day for more than 10 days) within 3 months of screening.
- Topical and inhaled glucocorticoids will be allowed
- Administration of any of the following treatment within 3 months of screening:
- Growth hormone (subjects on stable dose of growth hormone for at least 3 months prior to screening will be allowed)
- Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment on another investigational drugstudy(s), or current or planned participation in a clinical trial that would preclude compliance with study requirements Other inclusion/exclusion criteria may apply.
Trial locations and contacts
49 sites in 13 countries.
49 sites in 13 countries
United States13 sites
Research Site
Aurora, Colorado, 80045
Research Site
Baltimore, Maryland, 21205
Research Site
Boston, Massachusetts, 02115
Research Site
Decatur, Georgia, 30033
Research Site
Houston, Texas, 77030
Research Site
Indianapolis, Indiana, 46202
Research Site
Iowa City, Iowa, 52242
Research Site
Los Angeles, California, 90027
Research Site
Nashville, Tennessee, 37232
Research Site
New Haven, Connecticut, 06510
Research Site
Omaha, Nebraska, 68114
Research Site
Torrance, California, 90502
Research Site
Wilmington, Delaware, 19803
Czechia5 sites
Research Site
Hradec Králové, 500 05
Research Site
Pardubice, 532 03
Research Site
Pilsen, 305 99
Research Site
Prague, 140 59
Research Site
Zlín, 762 75
France5 sites
Research Site
Bordeaux, 33076
Research Site
Paris, 75012
Research Site
Paris, 75743
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Toulouse, 31059
Poland4 sites
Research Site
Bialystok, 15-274
Research Site
Lodz, 91-738
Research Site
Rzeszów, 35-301
Research Site
Warsaw, 04-730
United Kingdom4 sites
Research Site
Birmingham, B4 6NH
Research Site
Bristol, BS2 8AE
Research Site
Glasgow, G51 4TF
Research Site
Sheffield, S10 2TH
Belgium3 sites
Research Site
Brussels, 1200
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Bulgaria3 sites
Research Site
Sofia, 1606
Research Site
Sofia, 1784
Research Site
Varna, 9010
Canada3 sites
Research Site
Montreal, Quebec, H4A 0A9
Research Site
Ottawa, Ontario, K1H 8L1
Research Site
Toronto, Ontario, M5G 1X8
Spain3 sites
Research Site
Esplugues de Llobregat, Catalonia, 08950
Research Site
Getafe, Madrid, 28905
Research Site
Valencia, Valencia, 46026
Australia2 sites
Research Site
Subiaco, Western Australia, 6008
Research Site
Westmead, New South Wales, 2145
About this study
Official title: To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
Read the detailed description
To evaluate the effect of denosumab in lumbar spine bone mineral density (BMD) Z-score at 12 months, as assessed by dual-energy X-ray absorptiometry (DXA), in children 2 to 17 years of age (at the time of screening) on a 3-Month Dosing Regimen with osteogenesis imperfecta (OI)
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Denosumab
- Keywords
- Amgen, OI, Bone
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | Participants received denosumab 1 mg/kg (up to a maximum of 60 mg) subcutaneously every 6 months (Q6M) for up to 36 months.
Early efficacy and PK data from Q6M dosing supported adjustment of the dosing regimen from Q6M to every 3 months (Q3M). Participants enrolled and still receiving denosumab were transitioned from Q6M to Q3M dosing schedule. Participants could transition to Q3M dosing schedule up to and including the date they attended for their month 36 visit under the Q6M dosing regimen. Those participants received denosumab during the Q3M dosing regimen for 12 months. Participants who transition to Q3M at month 18 of the Q6M dosing regimen received denosumab Q3M for up to 18 months. Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-Score at 12 Months
Lumbar spine BMD was measured by dual-energy X-ray absorptiometry (DXA) adjusted for age, sex, and race/ethnicity. The results were then converted to Z-scores. The Z-score indicated the number of standard deviations away from the reference population and a score of 0 is equal to the mean. Positive changes from Baseline indicated an improvement in lumbar spine BMD.
Measured: Baseline and 12 months
Secondary outcomes (15)
Change From Baseline in Lumbar Spine BMD Z-score at 6 Months
Lumbar spine BMD was measured by DXA adjusted for age, sex, and race/ethnicity. The results were then converted to Z-scores. The Z-score indicated the number of standard deviations away from the reference population and a score of 0 is equal to the mean. Positive changes from Baseline indicated an improvement in lumbar spine BMD.
Measured: Baseline and 6 months
Change From Baseline in Proximal Femur BMD Z-score at 6 and 12 Months
Proximal femur (total hip and femoral neck) BMD Z-score was measured by DXA adjusted for age, sex, and race/ethnicity. The results were then converted to Z-scores. The Z-score indicated the number of standard deviations away from the reference population and a score of 0 is equal to the mean. Positive changes from Baseline indicated an improvement in lumbar spine BMD.
Measured: Baseline, 6 and 12 months
Percentage of Participants With at Least 1 X-ray Confirmed Long Bone or New and Worsening Vertebral Fracture
Measured: Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months
Percentage of Participants With at Least 1 X-ray Confirmed New and Worsening Vertebral Fracture
Measured: Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months
Percentage of Participants With at Least 1 X-ray Confirmed New Vertebral Fracture
Measured: Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months
Percentage of Participants Wth at Least 1 X-ray Confirmed Improving Vertebral Fracture
Measured: Q3M Dosing Regimen: Baseline up to 12 months
Percentage of Participants With at Least 1 Vertebral and Nonvertebral Fracture
Measured: Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months
Change From Baseline in Child Health Questionnaire-Parent Form Physical Summary Score (CHQ-PF-50) at 12 Months
The CHQ-PF-50 was a 50-item questionnaire completed by the parents or guardians of children between 5 and 18 years of age. The 50 questions measure 14 domains which were summarized as the physical and psychological summary scores. Each summary score was transformed and could range from 0 to 100, with higher score indicating better physical and psychosocial health. A negative change from Baseline indicates decreased well-being.
Measured: Baseline and 12 months
Change From Baseline in CHQ-PF-50 Psychological Summary Score at 12 Months
The CHQ-PF-50 was a 50-item questionnaire completed by the parents or guardians of children between 5 and 18 years of age. The 50 questions measure 14 domains which were summarized as the physical and psychological summary scores. Each summary score was transformed and could range from 0 to 100, with higher score indicating better physical and psychosocial health. A positive change from Baseline indicates improved well-being.
Measured: Baseline and 12 months
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index Score at 12 Months
The disability domain (questions 1-54) of the CHAQ was used to measure the participant's assessment of physical functioning or the parent's assessment of the child's physical functioning. The disability index comprised of 8 categories (dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and activities). Scoring ranged from 1 to 5; 1 was "without any difficulty," 2 was "with some difficulty," 3 was "with much difficulty," and 4 was "unable to do." An answer of "not applicable" was scored as a 5, but was not counted. If a child required assistance from another person or used an aid or other device for any of the 8 categories, the minimum score for that category was recorded as a 3. The CHAQ questions were scored and converted to a total index score ranging from 0 to 3. Negative change from Baseline indicates an improvement.
Measured: Baseline and 12 months
Change From Baseline in Wong-Baker Faces Pain Rating Scale (WBFPRS) at 12 Months
Participants were asked to report their level of pain by choosing a face that best described their own pain (the corresponding number: 0, 2, 4, 6, 8, 10) were then recorded. The WBFPRS ranged from 0, "no hurt," to 10, "hurts worst". A negative change from baseline indicates an improvement.
Measured: Baseline and 12 months
Serum Concentration of Denosumab
Measured: Days 1 (predose), 10, 30, and 60, & weeks 12, 24, 36, 48, 60, 72 (end of study visit), early termination visit, & follow-up visit 12 weeks after last dose (average duration of treatment: 231 days)
Serum Bone Turnover Marker (BTM) - Serum Type I Collagen C Telopeptide
Measured: Baseline and Days 10 and 30, and Months 3, 6, 9, 12, 15 and 18
BTM - Bone-specific Alkaline Phosphatase (BSAP)
Measured: Baseline and Days 10 and 30, and Months 3, 6, 9, 12, and 15
Change From Baseline in Growth Velocity at 12 Months
Change from baseline in growth velocity was determined by calculating age-adjusted Z-scores for height, weight and body mass index (BMI).
Height-for-age Z-score was defined as the difference between the participant's height and the median height for the population with the same age and gender, divided by the population standard deviation.
The definitions of growth velocity based on weight and BMI were analogously calculated. To programmatically calculate the Z-scores, the National Center for Health Statistics percentiles growth charts, based on the 2000 Center for Disease Control and Prevention (CDC) (http://www.cdc.gov/growthcharts/c c_charts.htm), and the CDC Anthropometric Software Package 3.0 Z-scores were used.
During normal growth, the change in z-score for each of the three should equal 0. A positive change in any of the three indicates growth acceleration, whereas a negative change indicates deceleration.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study start24 Jun 2015
- Primary completion26 Mar 2022
- Study completion26 Mar 2022
Why it stopped: The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants
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 Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352753
- Sponsor's protocol ID
- 20130173
- Other IDs
- 2014-000184-40, 2014
- Acronym
- OI
- Status last verified
- Nov 2022
- First submitted
- 28 Jan 2015
- Last updated
- 28 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI
- ClinicalTrials.gov ID
- NCT02352753
- Acronym / sponsor ID
- OI / 20130173
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Amgen, OI, Bone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants
- Enrolment
- 153 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2015 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
Detailed description
To evaluate the effect of denosumab in lumbar spine bone mineral density (BMD) Z-score at 12 months, as assessed by dual-energy X-ray absorptiometry (DXA), in children 2 to 17 years of age (at the time of screening) on a 3-Month Dosing Regimen with osteogenesis imperfecta (OI)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: DenosumabParticipants received denosumab 1 mg/kg (up to a maximum of 60 mg) subcutaneously every 6 months (Q6M) for up to 36 months. Early efficacy and PK data from Q6M dosing supported adjustment of the dosing regimen from Q6M to every 3 months (Q3M). Participants enrolled and still receiving denosumab were transitioned from Q6M to Q3M dosing schedule. Participants could transition to Q3M dosing schedule up to and including the date they attended for their month 36 visit under the Q6M dosing regimen. Those participants received denosumab during the Q3M dosing regimen for 12 months. Participants who transition to Q3M at month 18 of the Q6M dosing regimen received denosumab Q3M for up to 18 months. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI Clinical severity of OI as defined by 2 or more prevalent vertebral compression fractures; OR1 prevalent vertebral compression fracture and 1 or more nonvertebral fractures within the previous 2 years; OR 3 or more fractures within the previous 2 years.
Key exclusion criteria (36 listed)
- Inability or unwillingness to comply with the requirements for frequent calcium and phosphorus monitoring for 14 days after the first dose of denosumab (only applies to the first 5 subjects age 11 to17 enrolled in the study and the first 5 subjects of any age meeting the criteria for increased bone turnover
- Currently unhealed fracture or osteotomy as defined by orthopedic opinion
- Osteotomy within 5 months of screening
- Evidence of untreated oral cavities or oral infections
- Recent or planned invasive dental procedure
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 |
|---|---|---|
| DenosumabSubcutaneous (SC) injection. | Drug | Denosumab |
Primary outcome
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-Score at 12 Months
Time frame: Baseline and 12 months
Lumbar spine BMD was measured by dual-energy X-ray absorptiometry (DXA) adjusted for age, sex, and race/ethnicity. The results were then converted to Z-scores. The Z-score indicated the number of standard deviations away from the reference population and a score of 0 is equal to the mean. Positive changes from Baseline indicated an improvement in lumbar spine BMD.
15 secondary outcomes
Change From Baseline in Lumbar Spine BMD Z-score at 6 Months
Time frame: Baseline and 6 months
Change From Baseline in Proximal Femur BMD Z-score at 6 and 12 Months
Time frame: Baseline, 6 and 12 months
Percentage of Participants With at Least 1 X-ray Confirmed Long Bone or New and Worsening Vertebral Fracture
Time frame: Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months
Percentage of Participants With at Least 1 X-ray Confirmed New and Worsening Vertebral Fracture
Time frame: Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months
Percentage of Participants With at Least 1 X-ray Confirmed New Vertebral Fracture
Time frame: Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months
Percentage of Participants Wth at Least 1 X-ray Confirmed Improving Vertebral Fracture
Time frame: Q3M Dosing Regimen: Baseline up to 12 months
Percentage of Participants With at Least 1 Vertebral and Nonvertebral Fracture
Time frame: Q6M Dosing Regimen: Last 12 months of treatment (median treatment duration was 730.0 days); Q3M Dosing Regimen: Day 1 up to 12 months
Change From Baseline in Child Health Questionnaire-Parent Form Physical Summary Score (CHQ-PF-50) at 12 Months
Time frame: Baseline and 12 months
Change From Baseline in CHQ-PF-50 Psychological Summary Score at 12 Months
Time frame: Baseline and 12 months
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index Score at 12 Months
Time frame: Baseline and 12 months
Change From Baseline in Wong-Baker Faces Pain Rating Scale (WBFPRS) at 12 Months
Time frame: Baseline and 12 months
Serum Concentration of Denosumab
Time frame: Days 1 (predose), 10, 30, and 60, & weeks 12, 24, 36, 48, 60, 72 (end of study visit), early termination visit, & follow-up visit 12 weeks after last dose (average duration of treatment: 231 days)
Serum Bone Turnover Marker (BTM) - Serum Type I Collagen C Telopeptide
Time frame: Baseline and Days 10 and 30, and Months 3, 6, 9, 12, 15 and 18
BTM - Bone-specific Alkaline Phosphatase (BSAP)
Time frame: Baseline and Days 10 and 30, and Months 3, 6, 9, 12, and 15
Change From Baseline in Growth Velocity at 12 Months
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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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.
MD study director
Amgen
49 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab in people with Osteogenesis Imperfecta, run by Amgen at 49 sites in 13 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 1 inclusion and 36 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: stopped early, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Czechia, France, Poland, United Kingdom and 8 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 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 28 Dec 2022). 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 Lumbar Spine Bone Mineral Density (BMD) Z-Score at 12 Months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2022.