Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile in a 12-week, Sham-controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Adverse Event Safety Endpoint
研究概览
简要总结
To conduct a sham-controlled study to rigorously evaluate the effect of Spry Belt treatment on key bone turnover markers (BTMs) over a 12-week period. The investigators will calculate the percentage and absolute changes from baseline for several BTMs for both the active and sham treatment groups.
详细描述
This will be a 12-week, randomized, controlled study with 90 subjects. At enrollment, subjects will be randomized to the Active Treatment or Sham Treatment. All subjects will receive dietary supplements (calcium and vitamin D) for the duration of the study. Subjects will be asked to self-administer daily at-home treatments with the device at least 5 times each week. The investigators will evaluate safety via adverse events reported to the research staff and via responses to a survey on potential side effects. DXA scans will be obtained at the Screening Visit and Visit 3 (Study Completion). Blood and urine will be collected at Day 0 (Visit 1), Week 6 (Visit 2), and Week 12 (Visit 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Research staff will not change any study procedures based on the subject's group placement. Blinding assessment will be done during the study visits 2 and 3. We will use an established blinding assessment.33 Subjects will be asked if they believe they are receiving the real treatment, sham/placebo treatment, or if they are uncertain. Answers will be asked and recorded by the research staff on the case report forms.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Had her last menstrual period at least one year prior to the time of study enrollment
- •Has low bone mass as defined by a DXA T-score between -1.0 and -2.49 for the femoral neck, total femur, or lumbar spine
- •Is 50 years of age or older
- •Can walk and stand without an assistive device
- •Is able to provide informed consent
- •Is able to understand spoken and written English
- •Is capable and willing to follow all study-related procedures
排除标准
- •Has a bone mineral density (BMD) at the femoral neck, total femur, or lumbar spine of T score ≤ -2.5 (defined by DXA)
- •Has a 10-year probability of major fracture >20% or hip fracture >3% based on results of the Fracture Risk Assessment (FRAX) Tool (at screening)
- •Is currently taking or has taken oral bisphosphonates or other prescription osteoporosis medications in the past 24 months, or estrogen replacement therapy, glucocorticosteroids, dehydroepiandrosterone, tenofovir disoproxil fumarate, or other drugs affecting bone in the past 3 months
- •Has had at least one fracture or at least one major surgery within the past 6 months
- •Smokes >10 cigarettes per day over the past 6 months
- •Has had an average of 14 alcoholic drinks per week over the past 6 months
- •Has type I diabetes
- •Has a history of severe renal disease or kidney failure
- •Has had bariatric surgery
- •Has been diagnosed with chronic renal disease, cirrhosis, multiple myeloma, neuromuscular disease, osteomalacia, Paget's disease, osteogenesis imperfecta, severe osteoarthritis, rheumatoid arthritis, severe peripheral neuropathy, gastrointestinal malabsorption or sprue, an eating disorder (e.g., anorexia nervosa, bulimia), uncontrolled hypertension, or chronic diseases known to affect the musculoskeletal system (e.g., muscular dystrophy)
- •Has been diagnosed with an endocrine disorder known to adversely affect bone density, such as primary hyperparathyroidism, hyperthyroidism, or Cushing's syndrome, unless definitively treated
- •Has cancer and/or is being treated for cancer
- •Has had a bilateral oophorectomy
- •Is being treated for a herniated disc
- •Has had any prolonged immobilization (i.e., bedrest) for over one week or non-weight bearing for greater than one month of the axial or lower appendicular skeleton within the last 3 years
- •Is engaged in high-impact activity at least three times per week (including but not limited to tennis, aerobics, running, weight-bearing activity or exercise more intense than fast walking)
- •Has a known allergy to neoprene
- •Has a hip circumference >56 inches
- •Has a BMI >35
- •Has abnormal results for the following laboratory tests:
- •Serum 25(OH)D outside of the range: 10-100 ng/mL
- •Serum calcium outside of the normal laboratory ranges
- •Serum PTH outside of the normal laboratory ranges
- •TSH outside of the normal laboratory ranges*
- •FSH less than 40 (mIU/L) **
- •Has joint replacement implants in the ankle, knee, or hip
- •Has had a spinal fusion procedure
- •Has an active implant (e.g. implanted neurostimulator) in the areas of the lumbar or thoracic spine, pelvis, or buttocks
- •Has had a major change in high-impact physical activity level (increase or decrease) in the past 3 months
- •Has undergone or is undergoing transgender hormone therapy
- •Is deemed unsuitable for enrollment in the study by the Principal Investigator
结局指标
主要结局
Adverse Event Safety Endpoint
时间窗: 12 weeks
Adverse Events as recorded on the Adverse Event Case Report Form, showing number and type of Serious Adverse Events and Device Related-Adverse Events compared between the Active and Sham groups
Change from baseline for Urinary N-telopeptide (uNTX)
时间窗: 6 weeks
The percent change from Baseline for both Active and Sham treatment groups compared with a two-sample t-test with a significance level of 0.05.
次要结局
- Urine N-telopeptide (uNTX)(12 weeks)
- Serum amino-terminal propeptide of type 1 procollagen (P1NP)(12 weeks)
- Serum cross-linked C-telopeptide of type I collagen (sCTX)(12 weeks)
- DXA-based Total Femur Bone Mineral Density (aBMD)(12 weeks)
- Secondary Safety Endpoint(12 weeks)
- DXA-based Lumbar Spine Bone Mineral Density (aBMD)(12 weeks)
- Serum N-telopeptide (sNTX)(12 weeks)
- Quality of Life (QoL)(12 weeks)