Menopausal Osteoporosis Clinical Trial
Official title:
Effect of VSL#3 on Bone Mineral Density in Postmenopausal Women: a Pilot Randomized, Placebo-Controlled Trial
Osteoporosis has a devastating impact on quality of life of postmenopausal women, and is a
significant cause of disability and morbidity. Many drugs are approved for the prevention and
treatment of osteoporosis, but are associated with high costs and side effects. Some data
from animal studies suggests that supplementation with probiotics can safely treat and
prevent osteoporosis. The probiotic VSL#3 is commercially available, is safe for human
consumption, and has been widely used in human clinical trials, and has known
health-promoting effects in both children and adults.
The double-blind, randomized, placebo-controlled trial of VSL#3 will be conducted for 12
months in 40 postmenopausal women to determine if VSL#3 improves bone mineral density and
related bone markers. Study visits will include all or some of the following procedures: a
medical exam, urine collection, height and weight measurement, a blood draw to assess bone
biomarkers, a DEXA (dual energy X-ray absorptiometry) scan to measure bone density, and
health questionnaires.
This is one of the first clinical trials proposed to investigate the effects of probiotics in
bone in humans. If successful, this proposal will provide the first evidence that nutritional
supplementation with the probiotic VSL#3 is a safe and effective strategy for preventing
postmenopausal bone loss.
Osteoporosis has a devastating impact on quality of life of postmenopausal women, and is a
significant cause of disability and morbidity. Many drugs are approved for the prevention and
treatment of osteoporosis, but are associated with high costs and side effects. Some data
from animal studies suggests that supplementation with probiotics can safely treat and
prevent osteoporosis. The probiotic VSL#3 is commercially available, is safe for human
consumption, and has been widely used in human clinical trials, and has known
health-promoting effects in both children and adults.
The double-blind, randomized, placebo-controlled trial of VSL#3 will be conducted in a
population of ambulatory, otherwise healthy, postmenopausal women for 12 months. Control and
VSL#3-treated postmenopausal women will be matched by age (± 3 years). Study visits will
include all or some of the following procedures: a medical exam, urine collection, height and
weight measurement, a blood draw to assess bone biomarkers, a dual energy X-ray
absorptiometry (DEXA) scan to measure bone density, and health questionnaires.
The primary endpoint is the change in bone mineral density (BMD) at the L1-4 lumbar spine
over one year of study. Changes in BMD at the femoral neck and total hip area will be
secondary endpoints. All BMD data will also be used as a tool for future studies power
calculation and design. Additional endpoints will include changes in bone turnover markers
and inflammatory/osteoclastogenic cytokines. Measurements of indices of bone turnover and
cytokine levels will provide much needed mechanistic information.The data will allow to
establish whether VSL#3 prevents bone loss and/or increases bone mass by regulating bone
resorption, formation, or both.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06359353 -
Effect of Pitavastatin on Bone
|
Phase 4 |