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

Primary Purpose

Osteoporotic Fractures

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Denosumab
Teriparatide
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporotic Fractures focused on measuring osteoporosis, osteoporotic fractures, bone turnover markers, imaging biomarkers

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year; 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 <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 > 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    60mg of Denosumab treatment

    Teriparatide was sequentially treated with Denosumab

    Arm Description

    Outcomes

    Primary Outcome Measures

    The incidence of new vertebral fractures
    The incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2023
    Last Updated
    May 9, 2023
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05866029
    Brief Title
    Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
    Official Title
    Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporotic Fractures
    Keywords
    osteoporosis, osteoporotic fractures, bone turnover markers, imaging biomarkers

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    2310 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    60mg of Denosumab treatment
    Arm Type
    Active Comparator
    Arm Title
    Teriparatide was sequentially treated with Denosumab
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Denosumab
    Intervention Description
    Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
    Intervention Type
    Drug
    Intervention Name(s)
    Teriparatide
    Intervention Description
    Teriparatide was sequentially treated with Denosumab
    Primary Outcome Measure Information:
    Title
    The incidence of new vertebral fractures
    Description
    The incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment
    Time Frame
    Within 24 months of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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; The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year; 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 <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 > 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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