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Secondary Prevention of Osteoporosis

Secondary Prevention of Osteoporosis: A Window of Opportunity in the Acute Rehabilitation Setting

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00421343
Enrollment
29
Registered
2007-01-12
Start date
2007-02-28
Completion date
2008-06-30
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

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

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.

Detailed description

Following a fracture, few persons are screened or treated for osteoporosis (Feldstein et al). It is not surprising, then, that the risk of future osteoporotic fractures remains high. Although little data exists on the secondary prevention of osteoporosis, calcium, vitamin D, and bisphosphonates have all been shown to be effective in the primary prevention of osteoporotic fractures, and they are likely beneficial in reducing secondary fractures as well. Targeting falls prevention is another approach that is likely effective in reducing the risk of fracture. In the U.S., acute rehabilitation (rehab) settings offer a unique environment to initiate osteoporotic therapy. Therefore, this study will develop and implement evidence based interventions for the secondary prevention of osteoporotic fractures in the acute rehab setting with the following objectives: Specific Aim I: Assess overall compliance with pharmacological and non-pharmacological interventions initiated in an acute rehab setting following a fragility fracture. Hypothesis: Non-compliant participants are less likely to show improvement in functional status, muscle strength, or vitamin D levels following the intervention. Specific Aim II: Describe the incidence of fragility fractures and falls in participants at 6-months and one-year following the osteoporotic intervention introduced during acute rehab. Hypothesis: Similar to community based studies, a number of participants will go on to experience repeat falls and resulting fractures within one-year of follow-up. Compliant participants are less likely to experience falls and fractures. Specific Aim III: Confirm the high prevalence of vitamin D deficiency in a rehab setting. Describe the relationship between changes in vitamin D levels in participants between baseline and 6-month follow-up and changes in functional outcomes. Hypothesis: There will be a direct association between a change in vitamin D levels and a change in functional status. Consecutive individuals admitted with the primary or secondary diagnosis of fracture in the rehabilitation unit of Hebrew Rehabilitation Center will be offered enrollment. All participants enrolled will receive the same intervention: calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention interventions. Specific interventions for preventing falls include optimization of visual acuity, a review of medications associated with falls, personalized exercises to improve strength and balance, and a home hazards safety evaluation when indicated. All participants will have their functional status, muscle strength, and vitamin D level measured at baseline during their rehab stay. At the six-month follow-up, a home visit will be performed for all participants to again assess functional status, muscle strength, vitamin D level, satisfaction with the intervention, and reasons for non-compliance. A history of interim falls and fractures will be collected by telephone interviews, during home nursing visits, and during the exit 6-month visit.

Interventions

DRUGalendronate with cholecalciferol

alendronate 70mg /cholecalciferol 2800IU orally once weekly

DRUGcalcium carbonate with cholecalciferol

calcium carbonate 500mg /cholecalciferol 200IU orally twice daily

BEHAVIORALFalls prevention measures

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
GlaxoSmithKline
CollaboratorINDUSTRY
Hebrew SeniorLife
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Number Adherent With the Intervention6 months

Secondary

MeasureTime frameDescription
Reasons for Non-willingness to Particiapte and Non-adherence With Intervention6 monthsWe asked participants who would not participate the primary reason for non-particiaption. We also asked participants who were not adherent with recommendations what the primary reason ws for non-adherence.

Countries

United States

Participant flow

Participants by arm

ArmCount
Osteoporosis Medication
Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
29
Total29

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath1
Overall StudyLost to Follow-up3
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicOsteoporosis Medication
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
28 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
Age, Continuous80 years
STANDARD_DEVIATION 10
Region of Enrollment
United States
29 participants
Sex: Female, Male
Female
26 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 29
serious
Total, serious adverse events
1 / 29

Outcome results

Primary

Number Adherent With the Intervention

Time frame: 6 months

ArmMeasureValue (NUMBER)
Osteoporosis MedicationNumber Adherent With the Intervention29 participants
Secondary

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

We asked participants who would not participate the primary reason for non-particiaption. We also asked participants who were not adherent with recommendations what the primary reason ws for non-adherence.

Time frame: 6 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026