Secondary Prevention of Osteoporosis

NCT00421343 | Completed Phase 3 Results

• 2 other identifiers: AG00745T32AG023480-03
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and implement an evidence based protocol for the secondary prevention of osteoporotic fractures and falls, and to determine how compliance with this intervention improves muscle strength and functional status following a fracture.

Conditions

Osteoporosis

Keywords

disease/disorder proneness/risk; osteoporotic fractures; accidental falls; aging

Outcome Measures

Primary Outcomes (1)

• Number Adherent With the Intervention

  6 months

Secondary Outcomes (1)

• Reasons for Non-willingness to Particiapte and Non-adherence With Intervention

  6 months

Study Arms (1)

Treatment for osteoporosis and falls

OTHER

calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention

Drug: alendronate with cholecalciferol; Drug: calcium carbonate with cholecalciferol; Behavioral: Falls prevention measures

Interventions

alendronate with cholecalciferol DRUG

alendronate 70mg /cholecalciferol 2800IU orally once weekly

Also known as: Fosamax Plus D®

Treatment for osteoporosis and falls

calcium carbonate with cholecalciferol DRUG

calcium carbonate 500mg /cholecalciferol 200IU orally twice daily

Also known as: Os-Cal with extra D

Treatment for osteoporosis and falls

Falls prevention measures BEHAVIORAL

personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications

Treatment for osteoporosis and falls

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Admitted to rehab unit with the primary or secondary diagnosis of fracture
• English speaking
• Cognitively able to provide consent or health care proxy available and willing to provide consent
• Willing to cooperate

You may not qualify if:

• Pathologic or periprosthetic fractures
• Creatinine clearance less than 15ml/minute
• Severe hypocalcemia
• Esophageal stricture or achalasia
• Taking other treatment for osteoporosis besides calcium or vitamin D in the past 6-months
• History of kidney stones in the past 6-months

Sponsors & Collaborators

• Hebrew SeniorLife: lead
• National Institute on Aging (NIA): collaborator
• Merck Sharp & Dohme LLC: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Hebrew SeniorLife

Boston, Massachusetts, 02131, United States

Location

Related Publications (5)

• Kamel HK. Secondary prevention of hip fractures among the hospitalized elderly: are we doing enough? J Clin Rheumatol. 2005 Apr;11(2):68-71. doi: 10.1097/01.rhu.0000158545.26370.5c.

  PMID: 16357705 BACKGROUND

• Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997 Sep 4;337(10):670-6. doi: 10.1056/NEJM199709043371003.

  PMID: 9278463 BACKGROUND

• Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA, Palermo L, Prineas R, Rubin SM, Scott JC, Vogt T, Wallace R, Yates AJ, LaCroix AZ. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA. 1998 Dec 23-30;280(24):2077-82. doi: 10.1001/jama.280.24.2077.

  PMID: 9875874 BACKGROUND

• Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;(4):CD000340. doi: 10.1002/14651858.CD000340.

  PMID: 14583918 BACKGROUND

• Feldstein A, Elmer PJ, Orwoll E, Herson M, Hillier T. Bone mineral density measurement and treatment for osteoporosis in older individuals with fractures: a gap in evidence-based practice guideline implementation. Arch Intern Med. 2003 Oct 13;163(18):2165-72. doi: 10.1001/archinte.163.18.2165.

  PMID: 14557214 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Disease Susceptibility; Osteoporotic Fractures

Interventions

Alendronate; Cholecalciferol; Fumigant 93; Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Results Point of Contact

• Title: Sarah Berry
• Organization: Hebrew SeiorLife

sarahberry@hrca.harvard.edu

617-971-5355

Study Officials

• Sarah D Berry, MD, MPH

  Harvard University, Hebrew Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 12, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 5, 2020
• Results First Posted: June 10, 2011

Record last verified: 2020-01

Locations

US (1)