Osteogenesis ImperfectaPhase 4TOPaZNCT03735537
Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid
A Phase 4 study testing Teriparatide Pen Injector and Zoledronic Acid in people with Osteogenesis Imperfecta, run by University of Edinburgh at 23 sites in 2 countries.
Trial summary
Osteogenesis imperfecta (OI) is an inherited skeletal disorder characterised by increased risk of fragility fractures. Bisphosphonates are frequently prescribed for adult patients with OI with the aim of preventing fractures but the evidence base for efficacy is poor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Teriparatide Pen Injector and Zoledronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 1 Nov 2016to 21 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years and over with a clinical diagnosis of Osteogenesis Imperfecta (OI)
- Patients willing and able to consent and comply with the study protocol
Who cannot join
- Current or previous treatment with an investigational (non-licensed experimental) drug with effects on bone metabolism
- Contraindication to teriparatide or zoledronic acid
- Women of childbearing potential not using highly effective methods of contraception
- Pregnancy
- Women that are breastfeeding
- Age < 18 years
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United Kingdom22 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZR
Royal Victoria Hospital
Belfast, BT12 6BA
Queen Elizabeth Hospital
Birmingham, B15 2TH
Bristol Royal Infirmary
Bristol, NS2 8HW
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Ninewells Hospital
Dundee, DD1 9SY
Western General Hospital
Edinburgh, EH4 2XU
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Leicester Royal Infirmary
Leicester, LE1 5WW
Royal Liverpool Hospital and Aintree Hospital
Liverpool, L7 8XP
Llandough University Hospital
Llandough, CF64 2XX
Guy's and St Thomas' Hospital
London, SE1 9RT
Manchester Royal Infirmary
Manchester, M13 9WL
James Cook University Hospital
Middlesbrough, PS4 3BW
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Nottingham City Hospital
Nottingham, NG5 1PD
Nuffield Orthopaedic Centre
Oxford, OX3 7HE
Northern General Hospital
Sheffield, S5 7AU
University Hospital Southampton
Southampton, S016 6YD
Royal National Orthopaedic Hospital
Stanmore, HA7 4LP
Haywood Community Hospital
Stoke-on-Trent, ST6 7AG
Wishaw General Hospital
Wishaw, ML2 0DP
About this study
Osteogenesis imperfecta (OI) is an inherited skeletal disorder characterised by increased risk of fragility fractures. Bisphosphonates are frequently prescribed for adult patients with OI with the aim of preventing fractures but the evidence base for efficacy is poor. Recent evidence suggests that the bone anabolic agent teriparatide (TPTD) increases bone mineral density (BMD) and may have the potential to prevent fractures in OI.
The purpose of the TOPaZ Trial is to investigate if a a two-year course of teriparatide (TPTD) followed by antiresorptive therapy with a single infusion of zoledronic acid (ZA) in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care
Read more
Adult patients with a clinical diagnosis of OI who are willing and able to give informed consent and who do not have contraindications to the study medications will be recruited from participating sites. Participants will be randomised 1:1 to receive either standard care for the duration of the trial or TPTD for 24 months followed by a single infusion of ZA, or another antiresorptive agent in the event that ZA is contraindicated.
Participants will attend recruiting centres for a Baseline/Screening visit, at 12 months, 24 months and at the end of the trial for formal study visits with telephone calls every 6 months from a site research nurse. Participants randomised to TPTD will also attend recruiting centre at regular intervals during the 24 month treatment period to collect new supplies of TPTD.
Read the detailed description
Osteogenesis imperfecta (OI) is an inherited skeletal disorder characterised by increased risk of fragility fractures. Bisphosphonates are frequently prescribed for adult patients with OI with the aim of preventing fractures but the evidence base for efficacy is poor. Recent evidence suggests that the bone anabolic agent teriparatide (TPTD) increases bone mineral density (BMD) and may have the potential to prevent fractures in OI.
The purpose of the TOPaZ Trial is to investigate if a a two-year course of teriparatide (TPTD) followed by antiresorptive therapy with a single infusion of zoledronic acid (ZA) in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care.
The trial has a number of secondary objectives which aim to investigate if a two-year course of TPTD followed by antiresorptive therapy with a single infusion of ZA in adults with OI reduces the total number of fractures, reduces the risk of vertebral fractures; or affects bone pain, quality of life and functional status as compared with standard care. There is also a planned mechanistic analysis to understand which baseline characteristics of adults with OI, such as age, clinical subtype of OI, genetic diagnosis, bone turnover, BMD, and previous treatment influences the occurrence of fractures and/or the response to treatment
Adult patients with a clinical diagnosis of OI who are willing and able to give informed consent and who do not have contraindications to the study medications will be recruited from participating sites. Participants will be randomised 1:1 to receive either standard care for the duration of the trial or TPTD for 24 months followed by a single infusion of ZA, or another antiresorptive agent in the event that ZA is contraindicated. Exclusion criteria include: current or previous treatment with an investigational (non-licensed experimental) drug with effects on bone metabolism, contraindication to TPTD or ZA, women of childbearing potential not using highly effective methods of contraception, pregnancy, women that are breastfeeding or age <18 years.
Participants will attend recruiting centres for a Baseline/Screening visit, at 12 months, 24 months and at the end of the trial for formal study visits with telephone calls every 6 months from a site research nurse. Participants randomised to TPTD will also attend recruiting centre at regular intervals during the 24 month treatment period to collect new supplies of TPTD.
The baseline assessment will include dual energy x-ray absorptiometry (DEXA), spine x-rays, safety bloods, medical and fracture history, pain (brief pain inventory, BPI) and quality of life (SF36, HAQ, EQ5D, PSQI). Blood will be taken for genetic analysis and for analysis of biochemical markers of bone turnover. In some centres, a high resolution quantitative CT scan (HRQCT) of the wrist and tibia will be performed. Participants will be seen after 12 months when bloods, questionnaires and HRQTC will be repeated; at 24 months when bloods, questionnaires, DEXA and HRQCT will be repeated. At the end of the study participants will undergo DEXA, spine x-rays, HRQCT and bloods and questionnaires will be repeated. Information on adverse events and fractures will be collected throughout the study and participants suspected to have fractures will have x-ray or other imaging to confirm the presence of fractures.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Teriparatide Pen Injector, Zoledronic Acid
- Keywords
- Fracture, Teriparatide
- Medical subject headings
- Osteogenesis Imperfecta, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teriparatide Pen InjectorDrug
Also called Forsteo, Forteo
Zoledronic AcidDrug
Also called Aclasta 5mg solution for infusion, Zoledronic acid 5mg/100ml solution for infusion
Any brand or preparation may be used to deliver the required dose of 5mg
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide and zoledronic acid | Active comparator | Teriparatide (TPTD) 20mcg daily using Teriparatide Pen Injector, given subcutaneously using a self-administered injection device for two years (24 months) followed by a single intravenous 5mg infusion of zoledronic acid. Receives: Drug: Teriparatide Pen Injector; Drug: Zoledronic Acid |
| Standard Care | No intervention | Continuation of existing bone modifying treatment (i.e. bisphosphonate treatment) or no active bone modifying treatment according to the clinical judgement of the local investigator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident clinical fractures validated by x-ray or other imaging
Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging as compared to standard care
Measured: Through study completion, approximately 5 years
Secondary outcomes (8)
Total number of incident vertebral fractures
Incident vertebral fractures assessed by imaging of the thoracic and lumbar spine and reviewed by an independent masked adjudicator using two spine x-rays collected at the start and end of the trial
Measured: Baseline (0) and Final Trial Visit (5 years after baseline)
Total number of fractures
Total number of fractures experienced by participant defined as combination of validated clinical fractures, vertebral fractures and fractures reported by participants where imaging was not performed, was not feasible or where results were inconclusive
Measured: Through study completion, approximately 5 years
Pain assessed by the Brief Pain Inventory (BPI) Short Form measure
Bone pain assessed by the Brief Pain Inventory (BPI) Short Form, a Patient Reported Outcome Measure completed at 4 time-points throughout the trial. The BPI gives two main scores - a pain severity score and a pain interference score. The pain severity score is calculated from the four questions (3-6) about pain intensity. Each item is rated from 0 (no pain) to 10 (pain as bad as you can imagine). The scores from the 4 questions are added together and then divided by 4, giving a severity score out of 10.
The pain interference score corresponds to Question 9 responses. The seven sub-items are rated from 0 (does not interfere) to 10 (completely interferes). The scores are added together and divided by 7, giving an interference score out of 10.
Question 2 (pain drawing diagram), Question 7 and Question 8 (pain relief treatment or medication) do not contribute to the scoring.
Measured: Baseline (0), 12 months, 24 months and Final Trial Visit (5 years after baseline)
Quality of life assessed by the SF-36 (v1) Quality of Life
The SF-36 questionnaire consists of 36 generic health questions: 8 health domains of the questionnaire, each of which are summarised (Physical functioning score (10 items), Role-physical score (4 items), Bodily pain (2 items), General health score (5 items), Vitality score (4 items), Social functioning score (2 items), Role-emotional score (3 items), and Mental health score (5 items)). The resulting score for each domain is standardized, to obtain values ranging from 0 to 100, with higher values indicating a better quality of life.Two overall summary measures (physical and mental component scores) are calculated.
Measured: Baseline, 12 months, 24 months and Final Trial Visit (5 years after baseline
Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) measure
Sleep quality as assessed by the Pittsburgh Sleep Quality Index, a Patient Reported Outcome Measure completed at 4 time-points throughout the trial. The Pittsburgh Sleep Quality Index contains 19 self-rated questions. The questions are combined to form seven 'component' scores, each of which has a range of 0-3 points.
In all cases, a score of 0 indicates no difficulty while a score of 3 indicates severe difficulty. The seven component scores are added to yield one global score, ranging from 0-21 points, 0 indicating no difficulty and 21 indicating severe difficulties in all areas.
Measured: Baseline (0), 12 months, 24 months and Final Trial Visit (5 years after baseline)
Functional status assessed by the Health Assessment Questionnaire (HAQ) measure
The HAQ includes 8 blocks of questions covering difficulties performing simple daily activities. There are 20 questions in total. A 4 point grading system is used to denote degree of difficulty (0=none, 1=some difficulty, 2=great difficulty, 3=not able to perform at all). Each item has a companion aids-devices variable used to record types of assistance the subject uses for his/her usual activities. These variables are coded from 0 to 3 (0 = No assistance is needed, 1 = A special device is used by the subject in his/her usual activities, 2 = The subject usually needs help from another person, 3 = The subject usually needs BOTH a special device AND help from another person). The highest score reported for any component question of the 8 categories determines the score for that category. A global score is calculated by summing the scores for each of the categories and dividing by the number of categories answered.
Measured: Baseline (0), 12 months, 24 months and Final Trial Visit (5 years after baseline)
Adverse events
All adverse events reported throughout the duration of the trial. Summarised by treatment and by severity, causality and seriousness, reporting both the number of events and the number of patients experiencing a given event.
Measured: Through study completion, approximately 5 years
Mechanistic analyses (ITT)
Relationship between gender, clinical OI subtype, lowest Bone Mineral Density T score at spine or hip (≤ -2.5 or > -2.5)), type of genetic mutation (mutations of COLIA1 or COLIA2 and biochemical markers of bone turnover with fracture occurrence and response to treatment. Descriptive statistics by treatment group for each subgroup will be presented.
The primary outcome, defined as the proportion of participants experiencing a clinical fracture validated by x-ray or other imaging, will be analysed for these subgroups. The interaction between subgroup and treatment will be included in the primary and secondary analysis models to determine if the treatment effect differs by subgroup.
Measured: Biological samples collected at Baseline (0), 12 months, 24 months and Final Trial Visit (5 years after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Nov 2016
- Primary completion28 Feb 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, parallel arm, open-label, phase IV randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Stuart Ralston, MD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735537
- Sponsor's protocol ID
- AC16092
- Other IDs
- 2016-003228-22, 2016
- Acronym
- TOPaZ
- Status last verified
- Jun 2026
- First submitted
- 9 Aug 2018
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised aggregate data only will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid
- ClinicalTrials.gov ID
- NCT03735537
- Acronym / sponsor ID
- TOPaZ / AC16092
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Fracture, Teriparatide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteogenesis imperfecta (OI) is an inherited skeletal disorder characterised by increased risk of fragility fractures. Bisphosphonates are frequently prescribed for adult patients with OI with the aim of preventing fractures but the evidence base for efficacy is poor. Recent evidence suggests that the bone anabolic agent teriparatide (TPTD) increases bone mineral density (BMD) and may have the potential to prevent fractures in OI.
The purpose of the TOPaZ Trial is to investigate if a a two-year course of teriparatide (TPTD) followed by antiresorptive therapy with a single infusion of zoledronic acid (ZA) in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care
Adult patients with a clinical diagnosis of OI who are willing and able to give informed consent and who do not have contraindications to the study medications will be recruited from participating sites. Participants will be randomised 1:1 to receive either standard care for the duration of the trial or TPTD for 24 months followed by a single infusion of ZA, or another antiresorptive agent in the event that ZA is contraindicated.
Participants will attend recruiting centres for a Baseline/Screening visit, at 12 months, 24 months and at the end of the trial for formal study visits with telephone calls every 6 months from a site research nurse. Participants randomised to TPTD will also attend recruiting centre at regular intervals during the 24 month treatment period to collect new supplies of TPTD.
Detailed description
Osteogenesis imperfecta (OI) is an inherited skeletal disorder characterised by increased risk of fragility fractures. Bisphosphonates are frequently prescribed for adult patients with OI with the aim of preventing fractures but the evidence base for efficacy is poor. Recent evidence suggests that the bone anabolic agent teriparatide (TPTD) increases bone mineral density (BMD) and may have the potential to prevent fractures in OI.
The purpose of the TOPaZ Trial is to investigate if a a two-year course of teriparatide (TPTD) followed by antiresorptive therapy with a single infusion of zoledronic acid (ZA) in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care.
The trial has a number of secondary objectives which aim to investigate if a two-year course of TPTD followed by antiresorptive therapy with a single infusion of ZA in adults with OI reduces the total number of fractures, reduces the risk of vertebral fractures; or affects bone pain, quality of life and functional status as compared with standard care. There is also a planned mechanistic analysis to understand which baseline characteristics of adults with OI, such as age, clinical subtype of OI, genetic diagnosis, bone turnover, BMD, and previous treatment influences the occurrence of fractures and/or the response to treatment
Adult patients with a clinical diagnosis of OI who are willing and able to give informed consent and who do not have contraindications to the study medications will be recruited from participating sites. Participants will be randomised 1:1 to receive either standard care for the duration of the trial or TPTD for 24 months followed by a single infusion of ZA, or another antiresorptive agent in the event that ZA is contraindicated. Exclusion criteria include: current or previous treatment with an investigational (non-licensed experimental) drug with effects on bone metabolism, contraindication to TPTD or ZA, women of childbearing potential not using highly effective methods of contraception, pregnancy, women that are breastfeeding or age <18 years.
Participants will attend recruiting centres for a Baseline/Screening visit, at 12 months, 24 months and at the end of the trial for formal study visits with telephone calls every 6 months from a site research nurse. Participants randomised to TPTD will also attend recruiting centre at regular intervals during the 24 month treatment period to collect new supplies of TPTD.
The baseline assessment will include dual energy x-ray absorptiometry (DEXA), spine x-rays, safety bloods, medical and fracture history, pain (brief pain inventory, BPI) and quality of life (SF36, HAQ, EQ5D, PSQI). Blood will be taken for genetic analysis and for analysis of biochemical markers of bone turnover. In some centres, a high resolution quantitative CT scan (HRQCT) of the wrist and tibia will be performed. Participants will be seen after 12 months when bloods, questionnaires and HRQTC will be repeated; at 24 months when bloods, questionnaires, DEXA and HRQCT will be repeated. At the end of the study participants will undergo DEXA, spine x-rays, HRQCT and bloods and questionnaires will be repeated. Information on adverse events and fractures will be collected throughout the study and participants suspected to have fractures will have x-ray or other imaging to confirm the presence of fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, parallel arm, open-label, phase IV randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Teriparatide and zoledronic acid | Active comparator | Drug: Teriparatide Pen Injector, Drug: Zoledronic AcidTeriparatide (TPTD) 20mcg daily using Teriparatide Pen Injector, given subcutaneously using a self-administered injection device for two years (24 months) followed by a single intravenous 5mg infusion of zoledronic acid. |
| Standard Care | No intervention | –Continuation of existing bone modifying treatment (i.e. bisphosphonate treatment) or no active bone modifying treatment according to the clinical judgement of the local investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged 18 years and over with a clinical diagnosis of Osteogenesis Imperfecta (OI)
- Patients willing and able to consent and comply with the study protocol
Key exclusion criteria (6 listed)
- Current or previous treatment with an investigational (non-licensed experimental) drug with effects on bone metabolism
- Contraindication to teriparatide or zoledronic acid
- Women of childbearing potential not using highly effective methods of contraception
- Pregnancy
- Women that are breastfeeding
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 |
|---|---|---|
| Teriparatide Pen InjectorAlso: Forsteo, Forteo | Drug | Teriparatide and zoledronic acid |
| Zoledronic AcidAlso: Aclasta 5mg solution for infusion, Zoledronic acid 5mg/100ml solution for infusionAny brand or preparation may be used to deliver the required dose of 5mg | Drug | Teriparatide and zoledronic acid |
Primary outcome
Incident clinical fractures validated by x-ray or other imaging
Time frame: Through study completion, approximately 5 years
Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging as compared to standard care
8 secondary outcomes
Total number of incident vertebral fractures
Time frame: Baseline (0) and Final Trial Visit (5 years after baseline)
Total number of fractures
Time frame: Through study completion, approximately 5 years
Pain assessed by the Brief Pain Inventory (BPI) Short Form measure
Time frame: Baseline (0), 12 months, 24 months and Final Trial Visit (5 years after baseline)
Quality of life assessed by the SF-36 (v1) Quality of Life
Time frame: Baseline, 12 months, 24 months and Final Trial Visit (5 years after baseline
Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) measure
Time frame: Baseline (0), 12 months, 24 months and Final Trial Visit (5 years after baseline)
Functional status assessed by the Health Assessment Questionnaire (HAQ) measure
Time frame: Baseline (0), 12 months, 24 months and Final Trial Visit (5 years after baseline)
Adverse events
Time frame: Through study completion, approximately 5 years
Mechanistic analyses (ITT)
Time frame: Biological samples collected at Baseline (0), 12 months, 24 months and Final Trial Visit (5 years after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Trial webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Anonymised aggregate data only will be shared.
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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.
Stuart Ralston, MD principal investigator
University of Edinburgh
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teriparatide Pen Injector and Zoledronic Acid in people with Osteogenesis Imperfecta, run by University of Edinburgh at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incident clinical fractures validated by x-ray or other imaging (time frame: Through study completion, approximately 5 years). 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 11 Jun 2026.