Osteoporosis Clinical Trial
Official title:
Preventing Osteoporosis: The Effect of High Intensity Strength Training on Bone Mineral Density in Young and Healthy Women
The current guidelines emphasize the prevention of bone loss, by building up bone mass in young age, as one of the most important measures to reduce the incidence of osteoporosis. Strength training and "explosive" exercises have been shown to have beneficial effects on bone mass and bone metabolism in both young and postmenopausal women. However, meta-analysis concludes that it is still unclear what type of exercises, intensity and execution that is most effective for skeletal adaptations. The following study will examine the effect of 12 weeks of heavy, explosive strength training on bone mineral density and bone metabolism in young, healthy girls aged 18-30 years.
Background:
Osteoporosis is a progressive, systemic skeletal disorder characterized by low bone mineral
density (BMD), and deterioration of the microarchitecture of bone tissue, with a consequent
increase in bone fragility and susceptibility to fracture. Typically the disease shows no
symptoms until a fracture occurs, hence referred to as the "silent epidemic". In Norway one
of two women and one of four men experience a fragility fracture after the age of 50. The
loss of bone strength with age likely reflects the skeletal response to hormonal changes and
the mechanical environment with decreased physical activity. Osteoporotic fractures often
happen as a consequence of minimal injury, especially at the hip, spine and wrist. Hip
fracture is associated with excess mortality during the first year after fracture ranging
from 8.4% to 36%. The increased mortality risk may persist for several years thereafter,
highlighting the need for interventions to reduce this risk. Osteoporosis is a common
disease and recognized as a global problem by the WHO.
The American College of Sport Medicine suggests exercise as a countermeasure against bone
loss in postmenopausal woman and elderly subjects. Peak bone mass is thought to be attained
by the end of the third decade, hence the early adult years might be the final opportunity
for its augmentation. It is indicated that optimizing peak bone mass may have long-term
effect on bone health. Intervention studies with young women show that high impact exercises
may improve BMD in young adults. High intensity strength training also seems to effectively
improve BMD and the ratio of bone turnover markers. Furthermore, an explosive execution of
movement may be important for obtaining BMD improvements from resistance training. Maximal
strength training (MST) is characterized by high mobilization of force, high loads, and few
repetitions (3-5 reps.) per set with emphasis on maximal force mobilization in the
concentric part of the movement. Recent studies have shown that MST is highly efficient for
improving maximal strength (1RM) and rate of force development (RFD). Parameters such as 1RM
and RFD are closely related to BMD. In addition, a recent study from our group showed that
12 weeks of MST training (three times each week) improved bone mass in the hip and spine of
postmenopausal women, diagnosed with osteoporosis (article in preparation). In the present
study we want to investigate the impact of heavy, explosive strength training on bone mass
and bone metabolism in young and healthy woman which have not yet reached peak bone mass.
Physical activity and BMD:
One of the main factors responsible for the high incidence of osteoporosis is physical
inactivity. Several studies have shown that physical activity can lead to an increase in
BMD. Resistance- and impact exercises have shown to be most effective. A number of studies
performed with sedentary young women performing high impact training has shown significant
improvement in BMD at the femoral neck and lumbar spine. A study with postmenopausal women
showed that power training is more effective in maintaining BMD in the lumbar spine and
total hip than conventional strength training.
The effect of training at the cellular and tissue level can be divided into 3 main factors:
- Increased osteoblast activity and bone formation
- Reduced osteoclast activity and bone resorption
- Increased stability of the bone's architectural structure
In terms of prevention of osteoporosis the current exercise guidelines, according to the
WHO, is encouragement of a physically active lifestyle. Weight bearing activities,
preferably resistance training are recommended for patients with osteoporosis. Peak bone
mass is an important factor in determining long-term fracture risk. Therefore, effective
strategies to maximize peak bone mass in young adults are essential. Evidence indicates that
resistance and high-impact exercise are the most beneficial to maintain and optimize peak
bone mass in young adults. However, studies investigating such exercises are not altogether
conclusive, and the mode of exercise, regarding type of exercise, intensity and execution,
still remains unclear. Since MST exercise may increase bone mass in osteoporotic women, and
improves 1RM and RFD (which are closely related to skeletal health) we wish to investigate
the potential of MST training to increase bone mass and improve bone metabolism in young
female adults, who have not yet reached peak bone mass.
Goals of the study:
1. Investigate the effect of heavy, explosive strength training on bone mineral density
compared to a control group in young, healthy women over a period of 3 months.
2. Study the effect of this training intervention on bone formation and resorption markers
3. Study the effect on physical capacity measurements.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| 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 |
NCT02635022 -
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
|
||
| Recruiting |
NCT02616627 -
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
|
||
| 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 | |
| Not yet recruiting |
NCT02223572 -
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
|
N/A | |
| Completed |
NCT02559648 -
Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis
|
Phase 2 | |
| 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 |
NCT01401556 -
C-STOP Fracture Trial
|
N/A | |
| Completed |
NCT01694784 -
Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
|
N/A |