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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-90
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Denosumab

    Drug

    Active Comparator: 60mg of Denosumab treatment by subcutaneous injection

  • Teriparatide

    Drug

    Teriparatide was sequentially treated with Denosumab

Treatment groups

2,478 Participants
are divided into 2 treatment groups
Group A: 60mg of Denosumab treatmentActive comparator 1 intervention
Group B: Teriparatide was sequentially treated with DenosumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The main study:The incidence of new vertebral fractures

The main study:the incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment

Time frame
Within 24 months of treatment
2

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 outcomes

1

The main study:New vertebral fractures in 12 months

Time frame
Within 12 months of treatment
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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