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Completed

NCT Number: NCT01588509

Transition From Alendronate to Romosozumab (AMG 785)

The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
  • Low bone mineral density at screening [defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck]
  • Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance

Exclusion criteria

  • History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
  • History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
  • Vitamin D deficiency (defined as 25-OH-VitD levels < 20 ng/mL)

Treatment and study plan

Romosozumab

Drug

Administered by subcutaneous injection

Other names: AMG 785, EVENITY™

Primary outcomes

  1. Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine

    Time frame: Baseline and day 85

    Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab.

Secondary outcomes

  1. Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck

    Time frame: Baseline and day 85

    Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.

  2. Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip

    Time frame: Baseline and day 85

    Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.

  3. Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)

    Time frame: Baseline and days 4, 15, 29, 43, 57, 71, and 85

  4. Percent Change From Baseline in Serum C-telopeptide (sCTX)

    Time frame: Baseline and days 4, 15, 29, 43, 57, 71, and 85

  5. Number of Participants With Adverse Events

    Time frame: From first dose of study drug up to day 85

    An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant.

    Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events.

    A treatment-related adverse event (TRAE) was an adverse event assessed by the investigator as possibly related to the investigational product, indicated by a "yes" response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product?

    A serious adverse event was defined as an adverse event that met at least 1 of the following serious criteria:

    • fatal,
    • life-threatening,
    • required in-patient hospitalization or prolongation of existing hospitalization,
    • resulted in persistent or significant disability/incapacity,
    • congenital anomaly/birth defect, and/or
    • other medically important serious event.

  6. Number of Participants Who Developed Anti-romosozumab Antibodies

    Time frame: Baseline and days 29, 57, and 85

    Two validated assays were used to detect the presence of anti-romosozumab antibodies. An electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Samples testing positive in the immunoassay were further tested in a competitive binding bioassay for neutralizing activity against romosozumab. If a sample was positive for binding antibodies and demonstrated neutralizing activity, the participant was defined as positive for neutralizing antibodies. Participants who developed anti-romosozumab antibodies were those with a negative result at baseline and a positive result at any time postbaseline.

  7. Mean Serum Concentration of Romosozumab

    Time frame: Days 4, 15, 29, 43, 57, 71 and 85

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-label, Randomized Study to Estimate the Percent Change From Baseline in Lumbar Spine Bone Mineral Density After 3 Months of AMG 785 Administration in Postmenopausal Women With Low Bone Mineral Density Previously Treated With Alendronate

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 1, 2012
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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