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

JRCT ID: jRCT1031210596

Registered date:05/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: glucocorticoid-induced osteoporosis
• Date of first enrollment: 05/02/2022
• Target sample size: 132
• Study type: Interventional

Intervention(s)

<Exposure group>
Alendronate 35mg weekly
<Comparison group>
Alendronate 35mg weekly and Alfarol 0.5 micro g daily

Outcome(s)

• Primary Outcome: Changes in lumbar spine bone mineral density (g/ cm2) after 52 weeks from alendronate initiation

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Shunsuke Furuta
• Source(s) of Monetary Support: Department of Allergy and Clinical Immunology, Chiba University Hospital, Chiba, Japan.