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Effect of Physical Activity in Women With Manifest Osteporosis

NCT04768712 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-24

No results posted yet for this study

Summary

Objectives: To investigate if a physical activity intervention (one year) can reduce the risk of falls (primary endpoint), improve physical function (balance and muscle strength) and cortical bone geometry as well as trabecular microarchitecture (secondary endpoints) in women, 70-80 years old, with manifest osteoporosis, treated with zoledronic acid, calcium and vitamin D.

Strategic goal: To include 200 patients (100 intervention and 100 controls) during 2010 and 2011 and randomize 100 patients to a one year physical activity intervention (3 hours weekly). The results will be published in an international scientific peer-review journal. All patients will receive standard medical treatment with calcium, vitamin D and yearly zoledronic acid.

Study rationale: The role of physical activity intervention has not previously been evaluated in patients with manifest osteoporosis and zoledronic acid treatment.

Methodology: Randomized controlled trial. All included patients (women 70-80 years of age) will have manifest osteoporosis, be treatment naïve, and will be treated on clinical indication with yearly infusions of zoledronic acid (approved treatment, for this patient category, by the Swedish Medical Products Agency). Patients with secondary osteoporosis, with disabilities, and with high levels of exercise at the baseline visit will be excluded. Intention to treat analysis will be used. Physical activity intervention includes 3 hours of weight bearing aerobic exercise per week, using a standardized program. Patients in both groups will be contacted monthly and asked about their exercise habits. Frequency of falls, physical activity level will be ascertained using questionnaires. Balance and muscle strength will be assessed using standardized tests. Bone geometry at the tibia diaphysis will be determined using an XCT2000 pQCT device (Stratec, Germany) and trabecular microarchitecture at the tibia metaphysis will be determined using an XtremeCT device (Scanco Medical AG, Switzerland). These examinations will be performed on all patients prior to the intervention and after the completion of the study.

Conditions

Interventions

BEHAVIORAL

Weight bearing aerobic exercise

Weight bearing aerobic exercise three times per week.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-10
Primary Completion
2012-06-10
Completion
2012-06-10

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04768712 on ClinicalTrials.gov