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A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis

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ClinicalTrials.gov Identifier: NCT03432533
Recruitment Status : Active, not recruiting
First Posted : February 14, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)

Condition or disease Intervention/treatment Phase
Post-Menopausal Osteoporosis Drug: HCP administration with PFS Device: Subject self-administration with AI/Pen Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

After signing the informed consent form (ICF), subjects will undergo the following periods:

  • Screening period (35 days) to complete eligibility assessments
  • Open-label treatment period (6 months)
  • Follow-up period (3 months) During the open-label treatment period, subjects will be randomized to receive romosozumab either via HCP administration with PFS or via self-administration withAI/Pen.

During the follow-up period, subjects will be followed for an additional 3 months to ensure appropriate follow-up for anti-romosozumab antibody formation and adverse events.

The primary analysis will be performed after all subjects have had the opportunity to complete the Month 6 visit. The final analysis will be performed after all subjects have had the opportunity to complete the Month 9 visit.

Masking: None (Open Label)
Masking Description: This is an open-label study; blinding procedures are not applicable.
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : April 16, 2019
Estimated Study Completion Date : July 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Active Comparator: HCP administration with PFS
During the open-label treatment period, subjects will receive 210 mg romosozumab SC QM either by HCP administration with 2 PFS
Drug: HCP administration with PFS
subjects will receive 210 mg romosozumab SC QM either by HCP administration with 2 PFS

Active Comparator: Subject self-administration with AI/Pen
During the open-label treatment period, subjects will receive 210 mg romosozumab SC QM either by self-administration with 2 AI/Pens.
Device: Subject self-administration with AI/Pen
subjects will receive 210 mg romosozumab SC QM either by self-administration with 2 AI/Pens




Primary Outcome Measures :
  1. Percent change from baseline in bone mineral density (BMD) at the lumbar spine [ Time Frame: month 6 ]
    Percent change from baseline in bone mineral density (BMD) at the lumbar spine


Secondary Outcome Measures :
  1. Percent changes from baseline in BMD at the total hip. [ Time Frame: Month 6 ]
    Percent changes from baseline in BMD at the total hip.

  2. Incidence of treatment-emergent adverse events [ Time Frame: Month 6 ]
    Incidence of treatment-emergent adverse events

  3. Incidence of subjects developing anti-romosozumab antibodies [ Time Frame: Month 6 ]
    Incidence of subjects developing anti-romosozumab antibodies

  4. Serum Chemistry [ Time Frame: Month 6 ]
    Change from baseline in serum chemistry

  5. Percent changes from baseline in BMD at femoral neck. [ Time Frame: Month 6 ]
    Percent changes from baseline in BMD at femoral neck.

  6. Incidence of treatment-emergent serious adverse events [ Time Frame: Month 6 ]
    Incidence of treatment-emergent serious adverse events

  7. Incidence of treatment-emergent adverse device effects [ Time Frame: Month 6 ]
    Incidence of treatment-emergent adverse device effects

  8. Systolic Blood Pressure [ Time Frame: Month 6 ]
    Changes from baseline of systolic blood pressure

  9. Diastolic Blood Pressure [ Time Frame: Month 6 ]
    Change from baseline of diastolic blood pressure

  10. Respiratory Rate [ Time Frame: Month 6 ]
    Change from baseline respiratory rate

  11. Heart Rate [ Time Frame: Month 6 ]
    Change from baseline in heart rate

  12. Temperature [ Time Frame: Month 6 ]
    Change from baseline in temperature

  13. Hematology [ Time Frame: Month 6 ]
    Change from baseline in hematology


Other Outcome Measures:
  1. Percent change in bone turnover markers procollagen type 1 N telopeptide (P1NP) [ Time Frame: Month 6 ]
    Percent change in bone turnover markers procollagen type 1 N telopeptide (P1NP)

  2. Serum romosozumab concentration at Month 1 [ Time Frame: Month 1 ]
    Serum romosozumab concentration at Month 1

  3. Percent change in bone resorption marker serum type I collagen C telopeptide (sCTX) [ Time Frame: Month 6 ]
    Percent change in bone resorption marker serum type I collagen C telopeptide (sCTX)

  4. Serum romosozumab concentration at Month 3 [ Time Frame: Month 3 ]
    Serum romosozumab concentration at Month 3

  5. Serum romosozumab concentration at Month 6 [ Time Frame: Month 6 ]
    Serum romosozumab concentration at Month 6



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent/assent prior to initiation of any studyspecific activities/procedures, or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
  • Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening)

    -≥ 55 to ≤ 90 years of age at the time of informed consent

  • Ambulatory
  • BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans -Subject has at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the principal investigator or designee
  • Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator or designee
  • Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets at least 2 of the following clinical risk factors for fracture

    • ≥ 70 years of age at the time of informed consent
    • BMD T-score ≤ -3.00 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans
    • current smoker
    • consumption of ≥ 3 glasses of alcohol a day
    • parental history of fragility (ie, osteoporosis-related) fracture
    • body weight ≤ 125 pounds/56 kilogram
  • Ability to follow and understand instructions and the ability to self-inject, per investigator judgement

Exclusion Criteria:

  • History of ONJ and/or AFF
  • History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
  • Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget's disease, sclerosteosis and osteopetrosis)
  • Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels < 20 ng/mL], as determined by the central laboratory. Vitamin D repletion will be permitted a nd subjects may be rescreened
  • Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by subject report or by chart review, per principal investigator evaluation
  • Current clinical hypothyroidism (unless well controlled on stable thyroid replacement therapy) by subject report or by chart review, per principal investigator evaluation normal range, per subject medical history. Uncontrolled hyperparathyroidism is defined as: parathyroid hormone (PTH) outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in normocalcemic subjects.
  • Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the ULN as assessed by the central laboratory

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432533


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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03432533     History of Changes
Other Study ID Numbers: 20150120
2017-003512-40 ( EudraCT Number )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Amgen:
Post-Menopausal osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases