on-inferiority testing of bisphosphonates versus activated VitD plus bisphosphonate monotherapy for glucocorticoid-induced osteoporosis

Phase 4

Recruiting

• Conditions: glucocorticoid-induced osteoporosis; D010024

• Registration Number: JPRN-jRCT1031210596
• Lead Sponsor: Shunsuke Furuta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-05
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Patients who meet all of the following conditions are eligible.
1) Patients who will be newly administrated glucocorticoids (higher than prednisolone 0.3mg/kg or equivalent) for systemic autoimmune diseases such as connective tissue diseases.
2) Patients with performance status (Eastern Coop erative Oncology Group) 0 or 1
3) Written consent must be obtained from the patient or the patient's guardian.
4) Patient must be 20 years of age or older at the time of consent.

Exclusion Criteria

Patients who meet any of the following conditions are not eligible.
1) A history of continuous systemic administration of glucocorticoids within 6 months. (Inhaled and topical glucocorticoids are acceptable, and even systemic administration is acceptable if used within one month.)
2) Prior use of any of the following osteoporosis drugs
a) bisphosphonate (BP)
b) selective estrogen receptor modulators
c) Activated VitD
d) Ca preparations
e) Denosumab
f) Teriparatide
g) Romosozumab
3) Patients who are unsuitable for the use of BP products in the following cases
a) Patients with severe renal impairment (creatinine clearance of less than 30).
b) Patients with oral problems and high risk of osteonecrosis of the jaw.
4) The patients have been taking supplements containing Ca or VitD.
5) There is scheduled surgery during this study.
6) Pregnant or lactating women and those who may or intend to become pregnant during this study (if pregnancy is suspected, a pregnancy reaction te st should be performed).
7) The high risk for an allergic reaction to this study drug.
8) There are a health, psychological, or social condition that interferes with participation in the study or evaluation of results, such as substance abuse.
9) Other conditions that may compromise patient safety in the conduct of the study or make compliance with the study protocol difficult.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in lumbar spine bone mineral density (g/ cm2) after 52 weeks from alendronate initiation

Secondary Outcome Measures

Name	Time	Method
<Secondary endpoints of efficacy><br>Change in bone metabolism markers (serum TRACP-5b- 1, TOTAL P1NP) at 26 weeks and 52 weeks <br>Change in bone density of left femur bone mineral density at 52 weeks<br>Incidence of fragility fracture during the study period<br>Change in lumbar spine bone mineral density (g/c m2)) after 52 weeks only in patients with serum 25 OH-D deficiency (<20 ng/ml)<br><Secondary endpoints of safety><br>Incidence of hypercalcaemia<br>Incidence of hypocalcemia<br>Incidence of osteonecrosis of the jaw<br>Number and incidence of serious adverse events<br><Exploratory endpoints><br>Change in lumbar spine bone mineral density (g/c m2) at 26 weeks after alendronate initiation <br>Change in serum VitD (1-25OHD, 25OHD) <br>Changes in serum Ca and P<br>Change in urine Ca and Cr<br>Changes in urine Ca and Cr<br>Changes in ucOC