Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture

Official title

Efficacy of Sequential Denosumab After Teriparatide for 6 Months Compared With Denosumab Monotherapy in Reducing Risk of Osteoporotic Fractures in Patients With New Fractures: a Multicenter Randomized Controlled Trial (STAND Study)

Overview

This project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies. By registering for follow-up studies on osteoporotic fractures, it is planned to obtain epidemiological data through registration and follow-up studies; A prospective treatment study for patients with osteoporotic fractures is planned to explore effective treatment strategies through randomized controlled trials; To study biomarkers for osteoporotic refractures, we plan to establish a biomarker warning model through multi omics research; To study imaging biomarkers for osteoporotic refractures, a new imaging technology is proposed to establish an imaging omics warning model.

Interventions

• Drug Denosumab
  Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
• Drug Teriparatide
  Teriparatide was sequentially treated with Denosumab

Primary outcome measures

• The main study：The incidence of new vertebral fractures [Time frame: Within 24 months of treatment]
• The sub study：The rate of change in BMD from baseline at lumbar spine in 24 months [Time frame: Within 24 months of treatment]

Secondary outcome measures (10)

• The main study：New vertebral fractures in 12 months [Time frame: Within 12 months of treatment]
• The main study：New hip fractures, new fractures at other sites, and all new fractures at 12 and 24 months [Time frame: Within 12 months and 24 months of treatment]
• The main study：The rate of BMD change from the baseline at the lumbar spine, total hip, and femoral neck in 12 and 24 months; [Time frame: Within 12 months and 24 months of treatment]
• The main study：The rate of changes from baseline in serum type 1 collagen cross-linked C-terminal peptide (β-CTX) and type 1 procollagen N-terminal propeptide (P1NP) at 6, 12, and 24 months [Time frame: 6, 12, and 24 months]
• The main study：The patients' adherence to treatment [Time frame: 24 months]
• The main study：Cost-effectiveness [Time frame: 24 months]
• The sub study：BMD change at lumbar spine in 12 months [Time frame: Within 12 months of treatment]
• The sub study：BMD changes at total hip and femoral neck in 12 and 24 months [Time frame: Within 12 months and 24 months of treatment]
• The sub study：Serum β-CTX and P1NP levels at 12 and 24 months [Time frame: 12 months and 24 months]
• The sub study：The incidence of new vertebral fractures, hip fractures, new fractures at other sites, and all new fractures in 12 and 24 months [Time frame: Within 12 months and 24 months of treatment]

Eligibility criteria

Inclusion criteria

• New brittle hip fractures;
• New brittle vertebral fractures;
• New other site fractures and/or total hip or neck of femur or L1-L4 T-value \< -1.0;
• Men or postmenopausal women;
• Age 45-90 years old;
• Ability to move autonomously

Exclusion criteria

• bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
• Having primary hyperparathyroidism or hypothyroidism;
• Had or have osteomyelitis of the jaw or necrosis of the jaw;
• GFR<30ml/min/1.73m2;
• Active infection that requires systematic treatment;
• Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years;
• Used teriparatide and denosumab for osteoporosis within 6 months;
• Used glucocorticoids (equivalent to \&gt;5 mg/day prednisone) for more than 10 days within 6 weeks;
• The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year( if used within one year, but the cumulative use is ≤ 1 month, the subject can be enrolled) ;
• Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;
• Have hypocalcemia and hypercalcemia;
• Unexplained elevation of alkaline phosphatase;
• A serious deficiency of vitamin D (25OHD \&lt;10ng/mL);
• Patients who have previously received external radiation or radiation therapy with bone implants;
• Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \&gt; 8.5%, and severe arrhythmias;
• Planned pregnancy and lactation at present or during the study period;
• Allergic to teriparatide and denosumab;
• Participating in clinical trials of other drugs at present;
• subjects do not suitable for this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 58 centers

• Beijing Friendship Hospital, Capital Medical University — Beijing
• Beijing Hospital — Beijing
• Beijing Pinggu Hospital — Beijing
• Beijing Shijingshan Hospital — Beijing
• Beijing Yanhua Hospital — Beijing
• Peking Union Medical College Hospital — Beijing
• Peking University Third Hospital — Beijing
• Jilin Province FAW General Hospital — Changchun
• … and 50 more centers

Publications

• Chi Y, Zhu Y, Yuan J, Pang Q, Cui L, Jiang Y, Jiajue R, Liu W, Wang O, Li M, Xing X, Li H, Xie G, Wu Y, Xia W. Efficacy of sequential denosumab after teriparatide for 6 months compared with denosumab monotherapy in reducing risk of osteoporotic fractures in patients with new fractures: a multicentre randomised controlled trial (STAND study) protocol. BMJ Open. 2026 Feb 26;16(2):e111364. doi: 10.11 PMID 41748193

Identifiers

NCT: NCT05866029 · 2022-PUMCH-D-006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗