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Trial record 78 of 108 for:    CALCIUM CATION

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)

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ClinicalTrials.gov Identifier: NCT01825785
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteopenia Drug: Romosozumab Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Women With Low Bone Mass
Actual Study Start Date : November 14, 2007
Actual Primary Completion Date : December 2, 2008
Actual Study Completion Date : December 2, 2008

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for 3 months.
Drug: Placebo
Administered by subcutaneous injection

Experimental: Romosozumab
Participants were randomized to receive romosozumab administered by subcutaneous injection at doses of 1 mg/kg Q2W, 2 mg/kg Q4W, 2 mg/kg Q2W, or 3 mg/kg Q4W for 3 months.
Drug: Romosozumab
Administered by subcutaneous injection
Other Names:
  • AMG 785
  • EVENITY™




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 169 days ]

    Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards.

    Relatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?'


  2. Number of Participants Who Developed Antibodies to Romosozumab [ Time Frame: Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169. ]

    All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing.

    Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline.



Secondary Outcome Measures :
  1. Time to Maximum Observed Concentration (Tmax) of Romosozumab [ Time Frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. ]
    Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL.

  2. Maximum Observed Concentration (Cmax) of Romosozumab [ Time Frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. ]
  3. Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab [ Time Frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. ]
    Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts)

  4. Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab [ Time Frame: Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169. ]
  5. Accumulation Ratio (AR) for Romosozumab [ Time Frame: Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169. ]
    The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose.

  6. Percent Change From Baseline in Bone Mineral Density of the Total Spine [ Time Frame: Baseline and days 29, 85, 127, and 169 ]
    Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab.

  7. Percent Change From Baseline in Bone Mineral Density at the Total Hip [ Time Frame: Baseline and days 29, 85, 127, and 169 ]
    Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.

  8. Percent Change From Baseline in Bone Mineral Density at the Femoral Hip [ Time Frame: Baseline and days 29, 85, 127, and 169 ]
    Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.

  9. Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius [ Time Frame: Baseline and days 29, 85, 127, and 169 ]
    Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.

  10. Percent Change From Baseline in Bone Mineral Density at the Total Wrist [ Time Frame: Baseline and days 29, 85, 127, and 169 ]
    Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.

  11. Percent Change From Baseline in Bone Mineral Density of the Whole Body [ Time Frame: Baseline and days 29, 85, 127, and 169 ]
    Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.

  12. Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) [ Time Frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 ]
  13. Percent Change From Baseline in Osteocalcin [ Time Frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 ]
  14. Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) [ Time Frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 ]
  15. Percent Change From Baseline in Serum C-telopeptide (sCTX) [ Time Frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 ]
  16. Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) [ Time Frame: Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169 ]
  17. Percent Change From Baseline in Sclerostin [ Time Frame: Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169 ]
  18. Change From Baseline in Ionized Calcium [ Time Frame: Baseline and day 169 (or earlier for participants who discontinued before day 169) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females between 45 to 80 years of age
  • Postmenopausal females
  • Low bone mineral density, defined by bone mineral density (BMD) T-scores between -1.0 and -2.5, inclusive, for the lumbar spine [L1-L4] or total evaluable vertebrae [if fewer than L1-L4] or total hip)
  • 25-hydroxyvitamin D ≥ 20 ng/mL
  • Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)

Exclusion Criteria:

  • Osteoporosis defined by bone mineral density (BMD) T-scores < -2.5 for the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4) or total hip
  • Diagnosed with any condition that would affect bone metabolism
  • Previous exposure to AMG 785

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): NCT01825785


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01825785     History of Changes
Other Study ID Numbers: 20060221
First Posted: April 8, 2013    Key Record Dates
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs