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

NCT00950950 | Completed Phase 1 Results

• 1 other identifier: 20090153
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low bone mass.

Conditions

Osteopenia

Keywords

Amgen; Postmenopausal; Bone Density

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius

  The polar moment of inertia is a geometric measurement used to predict bone quality, specifically the ability to resist torsion (twisting), and is highly correlated with fracture load at the distal radius. The polar cross-sectional moment of inertia was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.

  Baseline and days 29, 57, 85, 127, and 169

Secondary Outcomes (31)

• Percent Change From Baseline in Total Bone Area at the Distal Radius

  Baseline and days 29, 57, 85, 127, and 169

• Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius

  Baseline and days 29, 57, 85, 127, and 169

• Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius

  Baseline and days 29, 57, 85, 127, and 169

• Percent Change From Baseline in Cortical Bone Area at the Distal Radius

  Baseline and days 29, 57, 85, 127, and 169

• Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius

  Baseline and days 29, 57, 85, 127, and 169

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.

Drug: Placebo

Romosozumab

EXPERIMENTAL

Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.

Drug: Romosozumab

Interventions

Romosozumab DRUG

Administered by subcutaneous injection

Also known as: AMG 785, EVENITY™

Romosozumab

Placebo DRUG

Administered by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \> 40 mIU/mL and serum estradiol ≤ 20 pg/mL
• Low bone mineral density (BMD), defined as a 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)
• 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

You may not qualify if:

• 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
• weeks to 3 months of BP use requires a 9-month washout period
• to 6 months of BP use requires a 1-year washout period

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: August 3, 2009
• Study Start: August 18, 2009
• Primary Completion: August 19, 2010
• Study Completion: August 19, 2010
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-03