Clinical trial NCT05884372: Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.
Official title: Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoporosis in Postmenopausal Women
Lead sponsor: Xi'an Honghui Hospital
Sponsor class: OTHER
Collaborators: name: Chugai Pharma China Co., Ltd.
First posted: 2023-06-01
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density.

Secondary objective:

To compare the efficacy of denosumab with eldecalcitol or native vitamin D treatment in postmenopausal women with osteoporosis on bone turnover markers, serum PTH, serum calcium, serum phosphorus, muscle mass, muscle strength, body balance ability, and quality of life.


Eligibility criteria: Inclusion Criteria:

* 1.Postmenopausal patients with osteoporosis, measured by dual energy X-ray absorptiometry (DXA), the T value of lumbar spine, femoral neck or total hip BMD is ≤-2.5.
* 2.Voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

* 1.Suffering from hyperthyroidism, Cushing's syndrome, hypogonadism, poorly controlled diabetes mellitus (glycated hemoglobin \[HbA1c\>7.5%\]), or other diseases that may lead to secondary osteoporosis.
* 2.Patients who have received denosumab therapy before screening: received oral bisphosphonate treatment more than 3 years or received bisphosphonate treatment within 6 months before screening, glucocorticoids, calcitonin, vitamin K, active vitamin D, gonadotropin-releasing hormone agonists, isotopes Flavonoids, selective estrogen receptor modulators, or hormone replacement therapy.
* 3.Patients with urolithiasis revealed by B-ultrasound at screening.
* 4.Corrected serum calcium value at screening exceeds 2.6mmol/L (10.4mg/dL) or serum calcium value is lower than 2.12mmol/L(8 mg/dL) or hypercalciuria (\> 0.4 mg/dL GF), or chronic kidney disease (eGFR \< 30 mL/min/1.73 m2).
* 5.Patients with malignant tumors or patients with a history of malignant tumors within the previous 3 years.
* 6.Patients judged by investigators to be unsuitable as subjects.

Primary outcomes:
measure: the percent change from baseline at month 12 in BMD at the lumbar spine L1-4.
timeFrame: 12 months
Secondary outcomes:
measure: the percent change from baseline at month 6 in BMD at the lumbar spine L1-4.
timeFrame: 6 months
measure: the percent change from baseline at each visit in BMD at the femoral neck and total hip.
timeFrame: 12 months
measure: the percent change from baseline at each visit in serum CTX,P1NP,PTH.
timeFrame: 12 months
measure: the percent change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA.
timeFrame: 12 months
measure: the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS).
timeFrame: 12 months
measure: the score change from baseline at month 6 and month 12 in quality of life by 16-item Assessment of Health-Related Quality of Life in Osteoporosis,(ECOS-16).
timeFrame: 12 months
measure: Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year.
timeFrame: 12 months
measure: 1.the percent change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand.
timeFrame: 12 months
measure: the percent change from baseline at month 6 and month 12 in muscle strength by measuring grip strength.
timeFrame: 12 months
measure: the percent change from baseline at month 6 and month 12 in body balance ability by measuring Timed Up and Go (TUG).
timeFrame: 12 months
measure: the percent change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW).
timeFrame: 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Zeng,Yuhong
Study officials:
References: