Osteoporosis Clinical Trial
Official title:
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial
Verified date | April 2024 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this clinical trial is to investigate the effect of the OsteoStrong training method and the Individually Adapted and Combined Training on the bone health of older women with high fracture risk. Additionally, the aim is also to explore the participants' experiences of each training method. Participants will be randomised to either treatment arm A (OsteoStrong) or treatment arm B (Individually Adapted and Combined Training). Participants in both groups will train for nine months. Treatment arm A will train individually once a week and treatment arm B will train in a group twice a week. Both groups will have a training instructor who will supervise and give training instructions. Researchers will compare the groups to see the effects of the training methods on the participants' bone health among other outcome measures. The participants will be tested at baseline and post-intervention (9 months later).
Status | Completed |
Enrollment | 194 |
Est. completion date | February 14, 2024 |
Est. primary completion date | July 12, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 65 Years to 79 Years |
Eligibility | Inclusion Criteria: - Woman, 65-79 years old. - Vaccinated against Covid-19. - Be able to participate in nine months of training. - Untreated with Osteoporosis-medications, or have an ongoing treatment since at least one year back. Exclusion Criteria: - Ongoing treatment with Osteoporosis-medications with an onset within a year, or a previous treatment which was terminated within the last five years. - Ongoing treatment with Osteoporosis-medications that has been delayed for more than eight months for Denosumab, or more than 18 months for bisphosphonates. - Vertebral fracture, that have been diagnosed within three months. - Vertebral fracture or hip fracture, that have not previously been treated with Osteoporosis-medications or been assessed by a physician. - Bilateral hip replacements. - Symptomatic disc herniation, inguinal herniation or umbilical herniation. - Untreated hypertension. - Other diseases that can affect the results and participation in the study: malignant diseases, muscle dystrophy, secondary osteoporosis, or other conditions that would hinder study participation. - Ongoing treatment with oral cortisone pills (= 5 mg Prednisolone). - Conditions that hinders the conduction of impact microindentation with OsteoProbe: large edema, skin infection, allergy towards local anaesthetics. - Ongoing or previous training (within the last year) at OsteoStrong. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care | Huddinge | Stockholms Län |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Linkoeping University, Region Stockholm, The Swedish School of Sport and Health Sciences |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone Material Strength Index (BMSI) | Bone Material Strength Index measured with impact microindentation using OsteoProbe | Change from baseline at 9 months | |
Secondary | Bone Mineral Density (BMD) | Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA) | Change from baseline at 9 months | |
Secondary | Procollagen Type 1 N-terminal propeptide (S-PINP) | Bone biomarker | Change from baseline at 3 and 9 months | |
Secondary | Serum C-telopeptide cross-link type 1 collagen (S-CTX) | Bone biomarker | Change from baseline at 3 and 9 months | |
Secondary | Sclerostin | Bone biomarker | Change from baseline at 3 and 9 months | |
Secondary | Bone alkaline phosphatase (S-BALP) | Bone biomarker | Change from baseline at 3 and 9 months | |
Secondary | Self-rated health questionnaire (SF-36) | A questionnaire with multiple choice questions about general health | Change from baseline at 9 months | |
Secondary | Falls Efficacy Scale (FES) | A questionnaire about self-efficacy and fear of falling, 1-10, where 0 equals "not sure at all" and 10 equals "completely sure". Higher scores equals better outcome. | Change from baseline at 9 months | |
Secondary | Socialstyrelsens questionnaire for lifestyle habits | A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking | Change from baseline at 9 months | |
Secondary | Numerical Rating Scale (NRS) | A pain rating scale from 0-10, where 0 equals "no pain" and 10 equals "maximum/worst possible pain imaginable". Higher scores equals worse outcome. | Change from baseline at 3 and 9 months | |
Secondary | Back extension strength | Measuring back extension strength with Digimax | Change from baseline at 9 months | |
Secondary | Grip strength | Measuring grip strength with hand dynamometer (JAMAR) | Change from baseline at 9 months | |
Secondary | Chair stand test | 5 seconds, 30 seconds and time for making 50 chair stands | Change from baseline at 9 months | |
Secondary | Back extension endurance | Measuring back extension endurance with Sörensen's test | Change from baseline at 9 months | |
Secondary | Static sit-up | Sitting with the upper body in 45 degrees | Change from baseline at 9 months | |
Secondary | Lung capacity | Lung capacity measured with dynamic spirometry (Welch Allyn) | Change from baseline at 9 months | |
Secondary | One leg standing (eyes open) | Balance test | Change from baseline at 9 months | |
Secondary | One leg standing (eyes closed) | Balance test | Change from baseline at 9 months | |
Secondary | Two leg standing on a straight line (eyes open) | Balance test | Change from baseline at 9 months | |
Secondary | Two leg standing on a straight line (eyes closed) | Balance test | Change from baseline at 9 months | |
Secondary | Walking forward on a straight line | Balance test | Change from baseline at 9 months | |
Secondary | Walking backwards between to lines | Balance test | Change from baseline at 9 months | |
Secondary | BtrackS | Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed. | Change from baseline at 9 months | |
Secondary | Accelerometry | Accelerometers worn around the waist to measure physical activity levels for up to nine days. | Change from baseline at 9 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06287502 -
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
|
N/A | |
Completed |
NCT03822078 -
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
|
Phase 1 | |
Recruiting |
NCT05845021 -
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
|
N/A | |
Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
Completed |
NCT04736693 -
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
|
||
Not yet recruiting |
NCT06431867 -
Primary Care Management of Osteoporosis in Older Women
|
||
Completed |
NCT02922478 -
Role of Comorbidities in Chronic Heart Failure Study
|
||
Recruiting |
NCT02616627 -
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
|
||
Recruiting |
NCT02635022 -
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
|
||
Active, not recruiting |
NCT02617303 -
Prevention of Falls and Its Consequences in Elderly People
|
N/A | |
Completed |
NCT02566655 -
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
|
Phase 1 | |
Completed |
NCT02559648 -
Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis
|
Phase 2 | |
Not yet recruiting |
NCT02223572 -
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
|
N/A | |
Completed |
NCT03420716 -
Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
|
N/A | |
Not yet recruiting |
NCT01854086 -
Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday
|
N/A | |
Completed |
NCT02003716 -
DeFRA Questionnaire as an Anamnestic Form
|
N/A | |
Unknown status |
NCT01913834 -
Nasally and sc Administered Teriparatide in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02143674 -
Muscle Strengthening Exercises and Global Stretching in Elderly
|
N/A | |
Completed |
NCT01401556 -
C-STOP Fracture Trial
|
N/A |