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Postmenopausal OsteoporosisPhase 3NCT00936897

A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

A Phase 3 study testing Ibandronate and Denosumab in people with Postmenopausal Osteoporosis, run by Amgen.

Completed

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

Official record
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Trial summary

This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM. Read more about this study

Who is it for?
Ages 55 years and older, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
Ibandronate and Denosumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
833 participants
Where
No sites listed yet
Study dates
Jul 2009to Jan 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ambulatory, postmenopausal women (based on medical history) 55 years or older at screening
  • Postmenopause will be defined as no vaginal bleeding or spotting for at least 12 months
  • If the subject is 55 - 59 years old and there is uncertainty regarding menopausal status, confirmation of serum FSH (>= 50 mIU/mL) and serum estradiol (<= 20 pg/mL) must be obtained
  • If the subject is 60 years or older, evaluation of FSH and estradiol levels is not needed to confirm menopausal status
  • Have received their first prescription of daily or weekly bisphosphonate therapy at least 1 month prior to screening
  • May have received
Show all 19Show fewer
  • raloxifene, calcitonin, prior to initiation of daily orweekly bisphosphonate therapy.
  • up to 3 doses of monthly bisphosphonate prior to initiation of daily or weekly bisphosphonate therapy
  • calcium, and vitamin D
  • Hormone replacement therapy (e.g. estrogen use for mitigation of menopausal symptoms)
  • Subject has:
  • Stopped daily or weekly bisphosphonate therapy (is denoted as non-persistent) at least one month before the screening visit, or
  • Demonstrated low adherence to therapy assessed by a score of less than 6 on the OS-MMAS
  • Screening BMD (g/cm2) values, at the lumbar spine OR total hip, that occur within the following ranges, based on the particular scanner that is used:
  • GE Lunar Lumbar spine 0.700 < or = BMD < and = 0.940 Total hip 0.504 < or = BMD < or = 0.756
  • Hologic Lumbar spine 0.607 < or = BMD < or = 0.827 Total hip 0.454 < or = BMD < or = 0.698 Both the initial and the repeat DXA scan of the lumbar spine OR the total hip must meet the above eligibility criteria.
  • At least 2 lumbar vertebrae must be evaluable by DXA.
  • At least one hip must be evaluable by DXA (eg, no history of either bilateral hip replacement or pins in both hips)
  • Provide signed informed consent before any study-specific procedures are conducted

Who cannot join

  • Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
  • Current or prior use of medications prescribed for osteoporosis treatment other than oral daily or weekly bisphosphonate
  • Contraindicated to receive oral ibandronate 150mg PO QM, including
  • Hypersensitivity to ibandronate 150mg PO QM or other constituents of ibandronate 150mg PO QM tablets
  • Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia
  • Inability to stand or sit upright for at least 60 minutes
Show all 26Show fewer
  • Administration of any of the following treatments within 3 months of screening
  • Tibolone
  • Anabolic steroids or testosterone
  • Glucocorticosteroids (>= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of >= 50 mg)
  • Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)] - Repletion will be allowed and subjects may be re-screened
  • Evidence of any of the following per subject report, chart review or central laboratory result:
  • Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less that 30mL/min/1.73 m2 determined by the central laboratory
  • Current hypo- or hypercalcemia based on the central laboratory reference ranges
  • Active gastric or duodenal ulcer; or any history of significant gastrointestinal bleed requiring hospitalization or transfusion
  • Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
  • Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
  • Any metabolic bone disease or secondary cause of bone loss that is not controlled and may interfere with the interpretation of the findings
  • Previous participation in clinical trials with denosumab 60mg SC Q6M (regardless of treatment)
  • Received any solid organ or bone marrow transplant
  • Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
  • Known sensitivity to mammalian cell derived drug products
  • Known intolerance to calcium supplements
  • Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s)
  • Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
  • Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the study

About this study

Official title: A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.

Being tested
Ibandronate, Denosumab
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

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

  • IbandronateDrug

    Ibandronate 150mg PO QM (tablet)

  • DenosumabDrug

    denosumab 60mg SC Q6M (pre-filled syringe)

Study groups in NCT00936897
Study groupRoleWhat they receive
IbandronateActive comparatorIbandronate 150mg PO QM (tablet)
Receives: Drug: Ibandronate
DenosumabExperimentaldenosumab 60mg Subcutaneous Q6M (pre-filled syringe)
Receives: Drug: Denosumab

What is being measured

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

  1. Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

    Measured: Baseline to month 12

Secondary outcomes (3)

  1. Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1

    Measured: Baseline to month 1

  2. Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

    Measured: Baseline to Month 12

  3. Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

    Measured: Baseline to month 12

Timeline

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

  1. First posted10 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionNov 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
833 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00936897
Sponsor's protocol ID
20080562
Status last verified
Feb 2013
First submitted
9 Jul 2009
Last updated
11 Feb 2013
Data monitoring committee
No

Publications

  • Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.

    PubMed 31776637

  • Recknor C, Czerwinski E, Bone HG, Bonnick SL, Binkley N, Palacios S, Moffett A, Siddhanti S, Ferreira I, Ghelani P, Wagman RB, Hall JW, Bolognese MA, Benhamou CL. Denosumab compared with ibandronate in postmenopausal women previously treated with bisphosphonate therapy: a randomized open-label trial. Obstet Gynecol. 2013 Jun;121(6):1291-1299. doi: 10.1097/AOG.0b013e318291718c.

    PubMed 23812464

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibandronate and Denosumab in people with Postmenopausal Osteoporosis, run by Amgen.

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 19 inclusion and 26 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 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

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 29 Nov 2012). 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?

Total Hip Bone Mineral Density Percent Change From Baseline at Month 12 (time frame: Baseline to 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 NCT00936897, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.

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