Effect of Physical Activity in Women With Manifest Osteporosis

• ClinicalTrials.gov Identifier: NCT04768712
• Recruitment Status: Withdrawn
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Sponsor: Sahlgrenska University Hospital, Sweden
• Information provided by (Responsible Party): Mattias Lorentzon, Sahlgrenska University Hospital, Sweden

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Osteoporosis	Behavioral: Weight bearing aerobic exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Physical Activity on Physical Function, Falls and Bone Geometry - a Randomized Control Trial in Women With Manifest Osteoporosis
• Estimated Study Start Date: June 10, 2012
• Estimated Primary Completion Date: June 10, 2012
• Actual Study Completion Date: June 10, 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Weight bearing aerobic exercise	Behavioral: Weight bearing aerobic exercise; Weight bearing aerobic exercise three times per week.
No Intervention: Lifestyle counseling

Outcome Measures

Primary Outcome Measures :

1. Propensity to fall [ Time Frame: Through study completion, an average of 1 year ]
   Frequency of falls during time of intervention.

Secondary Outcome Measures :

1. Physical function (Balance and muscle strength) [ Time Frame: Prior to the intervention and after the completion (an average of 1 year) of the study ]
2. Trabecular microarchitecture [ Time Frame: Prior to the intervention and after the completion (an average of 1 year) of the study ]
3. Cortical bone geometry [ Time Frame: Prior to the intervention and after the completion (an average of 1 year) of the study ]

Eligibility Criteria

• Ages Eligible for Study: 70 Years to 80 Years (Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 70-80 years of age
• manifest osteoporosis, BMD T-score ≤2.5 SD at the lumbar spine and/or hip
• female
• walk without walking aid

Exclusion Criteria:

• male
• high level of exercise, ≥2 times/week, at baseline
• secondary osteoporosis
• previous treatment with bisphosphonate or other osteoporosis induced medicine

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Mattias Lorentzon, Professor, Consultant, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT04768712
• Other Study ID Numbers: VGFOUREG-81091
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases