The Effect of Semaglutide (Ozempic) on Bone Turnover in Patients With Increased Fracture Risk: a Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Procollagen type 1 N-terminal propeptide (P1NP)
研究概览
简要总结
The hypothesis for this study is that the GLP-1Ra Semaglutide has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 40-85 years at increased risk of bone fractures. Treatment involves injection of Semaglutide 1.34 mg/ml once a week or corresponding volume of placebo once a week for 52 weeks. The effect will be measured by bone markers in blood samples, bone scans, bone tissue tests (bone biopsy), and direct bone strength measured by microindentation at the start and end of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •T-score <-1 in hip or lower back, assessed by DXA scan and / or
- •Low-energy fracture within the last 3 years
排除标准
- •T-score <-2.5 in hip or lower back, assessed by DXA scan, although these individuals may be included if they prefer to participate or are not candidates for conventional therapy, e.g., by eGFR <35 or adverse reaction (influenza-like symptoms, allergic reaction, etc.) to, e.g., bisphosphonate therapy
- •Diabetes type 1 and 2
- •Heart failure similar to NYHA Class IV
- •Primary hyperparathyroidism
- •Vitamin D deficiency (<25 nM) (re-test after substitution acceptable)
- •Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR <20) or liver function (baseline phosphatase higher than twice upper limit (105 U/L)), rheumatism, celiac disease, hypogonadism, severe COPD, hypopituitarism, Cushing's disease
- •Antiresorptive or bone anabolic drugs for the last 12 months
- •Use of anabolic steroids in the previous year
- •History of pancreatitis
- •Allergy to the medicines used
- •Inability to give informed consent
- •BMI <20 kg / m2
研究组 & 干预措施
Semaglutide
Ozempic 1 mg (or highest tolerated dose) s.c. once weekly for 52 weeks (incl. titration)
干预措施: Ozempic (Drug)
Placebo
Placebo (saline) 1 mg (or highest tolerated dose) s.c. once weekly for 52 weeks (incl. titration)
干预措施: Placebo (Drug)
结局指标
主要结局
Procollagen type 1 N-terminal propeptide (P1NP)
时间窗: Baseline and 52 weeks
Percentage changes in bone formation marker P1NP from baseline and after 12 months
次要结局
- Bone mineral density (BMD)(Baseline and 52 weeks)
- Estimated bone strength(Baseline and 52 weeks)
- Total volumetric BMD(Baseline and 52 weeks)
- Trabecular volumetric BMD(Baseline and 52 weeks)
- Bone specific alkaline phosphatase (BALP)(Baseline and 52 weeks)
- Bone volume(Baseline and 52 weeks)
- Tartrate-resistant acid phosphatase (TRAP)(Baseline and 52 weeks)
- Collagen 1 cross link C-terminal telopeptide (CTX)(Baseline and 52 weeks)
- BMSi(Baseline and 52 weeks)
- Cortical volumetric BMD(Baseline and 52 weeks)
- Trabecular thickness(Baseline and 52 weeks)
- Cortical thickness(Baseline and 52 weeks)
- Osteocalcin(Baseline and 52 weeks)
- Cortical porosity(Baseline and 52 weeks)
- Bone formation rate(52 weeks)
研究者
Morten Frost
Associate professor, clinical staff specialist, PhD
Odense University Hospital