Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)

Study Description

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Brief Summary:

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Condition or disease	Intervention/treatment	Phase
Postmenopausal Osteoporosis	Drug: Romosozumab; Drug: Placebo; Drug: Denosumab	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	7180 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Actual Study Start Date :	March 15, 2012
Actual Primary Completion Date :	December 14, 2015
Actual Study Completion Date :	December 28, 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Romosozumab; Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.	Drug: Romosozumab; Administered by subcutaneous injection once a month (QM); Other Names: AMG 785; EVENITY™ Drug: Denosumab; Administered by subcutaneous injection once every 6 months (Q6M); Other Name: Prolia®
Placebo Comparator: Placebo; Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.	Drug: Placebo; Administered by subcutaneous injection once a month (QM) Drug: Denosumab; Administered by subcutaneous injection once every 6 months (Q6M); Other Name: Prolia®

Outcome Measures

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Primary Outcome Measures :

1. Incidence of vertebral fracture [ Time Frame: 12 Months ]
2. Incidence of vertebral fracture [ Time Frame: 24 Months ]

Secondary Outcome Measures :

1. Incidence of Fracture [ Time Frame: 12 Months ]
2. Changes In Bone Mineral Density from Baseline to 12 Months [ Time Frame: 12 Months ]
3. Incidence of Fracture [ Time Frame: 24 Months ]
4. Changes In Bone Mineral Density from Baseline to 24 Months [ Time Frame: 24 Months ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)

Exclusion Criteria:

• BMD T-score of ≤ -3.50 at the total hip or femoral neck
• History of hip fracture
• Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
• Use of agents affecting bone metabolism
• History of metabolic or bone disease (except osteoporosis)
• Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
• Current hyper- or hypocalcemia
• Current, uncontrolled hyper- or hypothyroidism
• Current, uncontrolled hyper- or hypoparathyroidism

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 243 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AmgenTrials clinical trials website 

Publications:

Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. Epub 2016 Sep 18.

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01575834 History of Changes
Other Study ID Numbers:	20070337; 2011-001456-11 ( EudraCT Number )
First Posted:	April 12, 2012
Last Update Posted:	May 10, 2017
Last Verified:	April 2017

Keywords provided by Amgen:

Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Additional relevant MeSH terms:

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases	Metabolic Diseases; Denosumab; Bone Density Conservation Agents; Physiological Effects of Drugs