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New study aims to find best drug sequence to stop bone breaks

NCT ID NCT05866029

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two treatment plans for people with osteoporosis who have already had a fracture. One group receives a bone-building drug (teriparatide) for 6 months followed by a bone-strengthening drug (denosumab), while the other group takes denosumab alone. The goal is to see which approach better prevents new fractures over 24 months. About 2,478 adults aged 45-90 with recent brittle fractures are being recruited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,478 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \&lt; -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 \&gt;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 \&lt;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 \&gt; 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

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Conditions

The condition(s) this trial relates to.

osteoporosis Osteoporotic Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporotic fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    58 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, China

  • Affiliated Hospital of Inner Mongolia Medical University

    RECRUITING

    Hohhot, China

  • Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, China

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Beijing Hospital

    RECRUITING

    Beijing, China

  • Beijing Pinggu Hospital

    RECRUITING

    Beijing, China

  • Beijing Shijingshan Hospital

    RECRUITING

    Beijing, China

  • Beijing Yanhua Hospital

    RECRUITING

    Beijing, China

  • Changhai Hospital

    RECRUITING

    Shanghai, China

  • Changzhou NO.2 People&amp;#39;s Hospital

    RECRUITING

    Changzhou, China

  • First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, China

  • Gansu Provincial Hospital

    RECRUITING

    Lanzhou, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, China

  • Hebei Medical University Third Hospital

    RECRUITING

    Shijiazhuang, China

  • Henan Provincial General Hospital

    RECRUITING

    Zhengzhou, China

  • Huadong Hospital Affiliated to Fudan University

    RECRUITING

    Shanghai, China

  • Huazhong University of Science and Technology Union Shenzhen Hospital

    RECRUITING

    Shenzhen, China

  • Jiangxi Provincial People&amp;#39;s Hospital

    RECRUITING

    Nanchang, China

  • Jilin Province FAW General Hospital

    RECRUITING

    Changchun, China

  • Kunshan Hospital of Traditional Chinese Medicine

    RECRUITING

    Suzhou, China

  • Liaocheng People&amp;#39;s Hospital

    RECRUITING

    Liaocheng, China

  • Ningbo NO.2 Hospital

    RECRUITING

    Ningbo, China

  • PKUCare Luzhong Hospital

    RECRUITING

    Zibo, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, China

  • People&amp;#39;s Hospital of Ningxia Hui Autonomous Region

    RECRUITING

    Yinchuan, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, China

  • Qinghai University Affiliated Hospital

    RECRUITING

    Xining, China

  • Second Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, China

  • Shanghai Changzheng Hospital

    RECRUITING

    Shanghai, China

  • Shanghai General Hospital

    RECRUITING

    Shanghai, China

  • Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

  • Shengli Oilfield Central Hospital

    RECRUITING

    Dongying, China

  • Shenzhen Shiyan People&amp;#39;s Hospital

    RECRUITING

    Shenzhen, China

  • Sichuan Provincial People&#39;s Hospital

    RECRUITING

    Chengdu, China

  • The Fifth Affiliated Hospital Sun Yat-sen University

    RECRUITING

    Zhuhai, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    RECRUITING

    Hefei, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • The First People&amp;#39;s Hospital of Changzhou

    RECRUITING

    Changzhou, China

  • The First People&amp;#39;s Hospital of Kunshan

    RECRUITING

    Suzhou, China

  • The Fourth Hospital of Harbin Medical University

    RECRUITING

    Haerbin, China

  • The Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, China

  • The Second Hospital of Jilin University

    RECRUITING

    Haerbin, China

  • The Second Hospital of Shandong University

    RECRUITING

    Jinan, China

  • The Second People&amp;#39;s Hospital of Dalian

    RECRUITING

    Dalian, China

  • The Second XIANGYA Hospital of Central South University

    RECRUITING

    Changsha, China

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Shenzhen, China

  • Tongji Hospital of Tongji University

    RECRUITING

    Shanghai, China

  • Weifang People&amp;#39;s Hospital

    RECRUITING

    Weifang, China

  • West China Fourth Hospital of Sichuan University

    RECRUITING

    Chengdu, China

  • Zhejiang Provincial People&amp;#39;s Hospital

    RECRUITING

    Hangzhou, China

  • Zhejiang Provincial People&amp;#39;s Hospital Bijie Hospital

    RECRUITING

    Guizhou, China

  • Zhongda Hospital Southeast University

    RECRUITING

    Nanjing, China

  • Zibo Central Hospital

    RECRUITING

    Zibo, China

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Other studies related to the condition(s) this trial covers.