Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis

NCT00680953 | Completed Phase 3 Results DMC

• 1 other identifier: AMG162-A-J301
• Study Type: interventional
• Target: 1,262
• Locations: 1 country
• Sites: 4

Brief Summary

Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo

  Baseline to 24 months

Secondary Outcomes (2)

• The Percentage of Non-vertebral Fractures

  Baseline to 24 Months

• Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.

  Baseline to 24 Months

Study Arms (3)

1

EXPERIMENTAL

Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).

Drug: Denosumab

2

PLACEBO COMPARATOR

Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).

Drug: Placebo

3

ACTIVE COMPARATOR

Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).

Drug: Alendronate sodium hydrate

Interventions

Denosumab DRUG

Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).

1

Placebo DRUG

Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).

2

Alendronate sodium hydrate DRUG

Oral tablet once a week for 24 months

3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Involutional (postmenopausal and senile) osteoporosis with prevalent fragility vertebral fractures

You may not qualify if:

• Any underlying condition,(other than BMD) that might have resulted in abnormal bone metabolism

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (3)

• Nakamura T, Matsumoto T, Sugimoto T, Hosoi T, Miki T, Gorai I, Yoshikawa H, Tanaka Y, Tanaka S, Sone T, Nakano T, Ito M, Matsui S, Yoneda T, Takami H, Watanabe K, Osakabe T, Shiraki M, Fukunaga M. Clinical Trials Express: fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis: denosumab fracture intervention randomized placebo controlled trial (DIRECT). J Clin Endocrinol Metab. 2014 Jul;99(7):2599-607. doi: 10.1210/jc.2013-4175. Epub 2014 Mar 19.

  PMID: 24646104 RESULT

• Sugimoto T, Matsumoto T, Hosoi T, Miki T, Gorai I, Yoshikawa H, Tanaka Y, Tanaka S, Fukunaga M, Sone T, Nakano T, Ito M, Matsui S, Yoneda T, Takami H, Watanabe K, Osakabe T, Okubo N, Shiraki M, Nakamura T. Three-year denosumab treatment in postmenopausal Japanese women and men with osteoporosis: results from a 1-year open-label extension of the Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT). Osteoporos Int. 2015 Feb;26(2):765-74. doi: 10.1007/s00198-014-2964-2. Epub 2014 Nov 18.

  PMID: 25403903 RESULT

• Okubo N, Matsui S, Matsumoto T, Sugimoto T, Hosoi T, Osakabe T, Watanabe K, Takami H, Shiraki M, Nakamura T. Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenopausal Women and Men with Osteoporosis. Calcif Tissue Int. 2020 Dec;107(6):559-566. doi: 10.1007/s00223-020-00750-y. Epub 2020 Aug 25.

  PMID: 32839843 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: H. Takami
• Organization: Daiichi Sankyo Co., Ltd.

takami.hideo.hs@daiichisankyo.co.jp

+81 3 5740 3445

Study Officials

• Daiichi Sankyo

  R&D Division, Daiichi Sankyo Co., Ltd.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 12, 2015
• Results First Posted: February 26, 2014

Record last verified: 2015-02

Locations

JP (4)