A Study to Evaluate the Effect of AMG 785 on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00950950
First received: July 30, 2009
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to evaluate the effect of AMG 785 on parameters of bone quality of the forearm using peripheral Quantitative Computed Tomography (pQCT) following multiple subcutaneous dose administrations of AMG 785 in postmenopausal women with low bone mass.


Condition Intervention Phase
Osteopenia
Drug: AMG 785
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Effect of AMG 785 on Parameters of Bone Quality of the Forearm Using pQCT in Postmenopausal Women With Low Bone Mineral Density

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Polar cross-sectional moment of inertia at the distal radius assessed by pQCT [ Time Frame: Throughout the trial duration (169 days) at screening and on days 29, 57, 85, 127 and 169 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parameters of bone quality (bone mineral content, bone area, bone mineral density, bone circumferences and axial cross-sectional moment of inertia) of the forearm assessed by pQCT [ Time Frame: Throughout the trial duration (169 days) at screening and on days 29, 57, 85, 127 and 169 ] [ Designated as safety issue: No ]
  • Pharmacokinetic and pharmacodynamic parameters (P1NP, sCTX and BMD of the lumbar spine and forearm by DXA) [ Time Frame: Throughout the trial duration (169 days) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B
Eleven female subjects will receive placebo.
Drug: AMG 785
Subjects will be randomized to receive subcutaneous dose administrations of AMG 785 or placebo at a dose of 3 mg/kg every 4 weeks for 3 months.
Active Comparator: A
Eleven female subjects will receive AMG 785.
Drug: Placebo
Subjects will be randomized to receive subcutaneous dose administrations of AMG 785 or placebo at a dose of 3 mg/kg every 4 weeks for 3 months.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females between 55 to 80 years of age
  • Postmenopausal females (based on medical history) defined as 12 continuous months of spontaneous amenorrhea
  • Women 60 years of age and older will be considered postmenopausal
  • Women 55-59 must have a serum follicle-stimulating hormone result ≥ 40mIU/mL and serum estradiol ≤ 20 pg/mL
  • Low bone mineral density [BMD, T-score between -1.0 and -2.5 at the lumbar spine (L1-L4) and/or femoral neck]
  • Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
  • 25-hydroxyvitamin D ≥ 20 ng/mL at screening
  • Willing and able to take ≥ 500 mg calcium and ≥ 400 IU (but ≤ 1,000 IU) vitamin D daily

Exclusion Criteria:

  • Osteoporosis, defined as a BMD T-score ≤ -2.5 at the lumbar spine or femoral neck
  • History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis
  • Diagnosed with any condition that will affect bone metabolism
  • Subjects with fewer than 2 evaluable vertebrae; metal in forearms bilaterally that would not allow for at least one evaluable forearm
  • Administration of the following medications within 6 months before study drug administration. This includes all routes of administration, for example intranasal and topical skin patches, unless otherwise noted:
  • Hormone replacement therapy [(eg, estrogen, estrogen-like compounds such as raloxifene). Infrequent use of estrogen vaginal creams (< 3 times per week) is allowed.]
  • Calcitonin
  • Parathyroid hormone (or any derivative)
  • Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed)
  • Anabolic steroids
  • Calcitriol, and available analogues
  • Administration of daily, weekly, or monthly bisphosphonates (BP) unless meeting the following criteria:
  • < 2 weeks of BP use requires a 2-month washout period
  • 2 weeks to 3 months of BP use requires a 9-month washout period
  • 3 to 6 months of BP use requires a 1-year washout period
  • > 6 months of BP use requires a 3-year washout period;
  • Greatly differing levels of physical activity or constant levels of intense physical exercise during the 6 months before study drug administration
  • Known sensitivity to mammalian-derived drug preparations
  • Known to be hepatitis B surface antigen, hepatitis C virus or Human Immunodeficiency Virus positive or a known diagnosis of Acquired Immunodeficiency Syndrome
  • Any organic or psychiatric disorder, which, in the opinion of the investigator, poses a risk to subject safety and may prevent the subject from completing the study or interfere with the interpretation of the study results
  • Unavailable for follow-up assessment or any concerns for subject's compliance with the protocol procedures
  • Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent
  • History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Clinically significant abnormality during the screening physical examination, ECG or laboratory evaluation
  • Participation in another clinical study within 4 weeks of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known
  • Has donated or lost 400 mL or more of blood or plasma within 8 weeks of study drug administration
  • Previous AMG 785 exposure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950950

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00950950     History of Changes
Other Study ID Numbers: 20090153
Study First Received: July 30, 2009
Last Updated: February 3, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Amgen:
Amgen
Postmenopausal
Bone Density

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

ClinicalTrials.gov processed this record on April 15, 2014