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

January 7, 2026 updated by: Peking Union Medical College Hospital

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2478

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Shijingshan Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Pinggu Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Yanhua Hospital
        • Contact:
      • Changchun, China
        • Recruiting
        • Jilin Province FAW General Hospital
        • Contact:
      • Changsha, China
        • Recruiting
        • The Second Xiangya Hospital Of Central South University
        • Contact:
      • Changzhou, China
        • Recruiting
        • Changzhou NO.2 People's Hospital
        • Contact:
      • Changzhou, China
        • Recruiting
        • The First People's Hospital of Changzhou
        • Contact:
      • Chengdu, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Chengdu, China
        • Recruiting
        • West China Fourth Hospital of Sichuan University
        • Contact:
      • Dalian, China
        • Recruiting
        • The Second People's Hospital of Dalian
        • Contact:
      • Dongying, China
        • Recruiting
        • Shengli Oilfield Central Hospital
        • Contact:
      • Guiyang, China
        • Recruiting
        • Affiliated Hospital of Guizhou Medical University
        • Contact:
      • Guizhou, China
        • Recruiting
        • Zhejiang Provincial People's Hospital Bijie Hospital
        • Contact:
      • Haerbin, China
        • Recruiting
        • The Fourth Hospital of Harbin Medical University
        • Contact:
      • Haerbin, China
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
      • Hefei, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
      • Hefei, China
        • Recruiting
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • Contact:
      • Hohhot, China
        • Recruiting
        • Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
      • Jinan, China
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
      • Jinan, China
        • Recruiting
        • The Second Hospital of Shandong University
        • Contact:
      • Jining, China
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
      • Lanzhou, China
        • Recruiting
        • Gansu Provincial Hospital
        • Contact:
      • Liaocheng, China
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
      • Nanchang, China
        • Recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
      • Nanjing, China
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
      • Ningbo, China
        • Recruiting
        • Ningbo No.2 Hospital
        • Contact:
      • Qingdao, China
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai General Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Huadong Hospital Affiliated to Fudan University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Changhai Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Tongji Hospital of Tongji University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shenzhen, China
        • Recruiting
        • Huazhong University of Science and Technology Union Shenzhen Hospital
        • Contact:
      • Shenzhen, China
        • Recruiting
        • Shenzhen Shiyan People's Hospital
        • Contact:
      • Shenzhen, China
        • Recruiting
        • The Seventh Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Shijiazhuang, China
        • Recruiting
        • Hebei medical university third hospital
        • Contact:
      • Suzhou, China
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Suzhou, China
        • Recruiting
        • Kunshan Hospital of Traditional Chinese Medicine
        • Contact:
      • Suzhou, China
        • Recruiting
        • The First People's Hospital of Kunshan
        • Contact:
      • Taiyuan, China
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
      • Taiyuan, China
        • Recruiting
        • Second Hospital of Shanxi Medical University
        • Contact:
      • Weifang, China
        • Recruiting
        • Weifang People's Hospital
        • Contact:
      • Wenzhou, China
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Xining, China
        • Recruiting
        • Qinghai University Affiliated Hospital
        • Contact:
      • Yinchuan, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
      • Yinchuan, China
        • Recruiting
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
      • Zhengzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, China
        • Recruiting
        • Henan Provincial General Hospital
        • Contact:
      • Zhuhai, China
        • Recruiting
        • The Fifth Affiliated Hospital Sun Yat-Sen University
        • Contact:
      • Zibo, China
        • Recruiting
        • PKUcare Luzhong Hospital
        • Contact:
      • Zibo, China
        • Recruiting
        • Zibo Central Hospital
        • Contact:
      • Ürümqi, China
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. New brittle hip fractures;
  2. New brittle vertebral fractures;
  3. New other site fractures and/or total hip or neck of femur or L1-L4 T-value < -1.0;
  4. Men or postmenopausal women;
  5. Age 45-90 years old;
  6. Ability to move autonomously

Exclusion Criteria:

  1. bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
  2. Having primary hyperparathyroidism or hypothyroidism;
  3. Had or have osteomyelitis of the jaw or necrosis of the jaw;
  4. GFR<30ml/min/1.73m2;
  5. Active infection that requires systematic treatment;
  6. Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years;
  7. Used teriparatide and denosumab for osteoporosis within 6 months;
  8. Used glucocorticoids (equivalent to >5 mg/day prednisone) for more than 10 days within 6 weeks;
  9. 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) ;
  10. Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;
  11. Have hypocalcemia and hypercalcemia;
  12. Unexplained elevation of alkaline phosphatase;
  13. A serious deficiency of vitamin D (25OHD <10ng/mL);
  14. Patients who have previously received external radiation or radiation therapy with bone implants;
  15. Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin > 8.5%, and severe arrhythmias;
  16. Planned pregnancy and lactation at present or during the study period;
  17. Allergic to teriparatide and denosumab;
  18. Participating in clinical trials of other drugs at present;
  19. subjects do not suitable for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 60mg of Denosumab treatment
Monotherapy with denosumab injection ( 60mg, subcutaneous injection, semi-annually) for 24 months.
Drug: Denosumab
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Experimental: Teriparatide was sequentially treated with Denosumab
  1. Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 6 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, once every six months) and continued until the 24th month.
  2. Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 12 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, semi-annually) treatment continued until the 24th month.
Drug: Denosumab
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Drug: Teriparatide
Teriparatide was sequentially treated with Denosumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main study：The incidence of new vertebral fractures
Time Frame: Within 24 months of treatment
The main study：the incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment
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
Within 24 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main study：New vertebral fractures in 12 months
Time Frame: Within 12 months of treatment
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
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
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
6, 12, and 24 months
The main study：The patients' adherence to treatment
Time Frame: 24 months

Non-adherence rate=Number of patients non-adherencet with teriparatide or denosumab / Total number of patients.

  1. Denosumab Adherence Adherence to denosumab treatment was assessed based on protocol compliance during the study period. Non-adherence was defined as one or more instances in which the scheduled denosumab injection was not administered according to the study protocol, including doses received outside the permissible treatment window (±4 weeks).
  2. Teriparatide Adherence Adherence to teriparatide was evaluated only in the two sequential treatment groups assigned to receive teriparatide. Using patient diary records, non-adherence was defined as an actual-to-expected injection day ratio of less than 80% or greater than 120% over the course of the study period.
24 months
The main study：Cost-effectiveness
Time Frame: 24 months
The incremental cost-effectiveness ratio is defined as the average additional drug cost required per additional fracture event avoided in the intervention group compared to the control group.
24 months
The sub study：BMD change at lumbar spine in 12 months
Time Frame: Within 12 months of treatment
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
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
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
Within 12 months and 24 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Weibo Xia, MD., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-PUMCH-D-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data related to this study will be made available upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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