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Evaluation for the non-inferiority between bisphosphonate monotherapy and bisphosphonate plus active vitamin D for preventing glucocorticoid induced osteoporosis in Japanese patients with systemic autoimmune diseases; An open-label, multicenter, randomized controlled study

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

Shunsuke Furuta

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN

shfuruta@chiba-u.jp

Kazuya Abe

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN

+81-43-222-7171

abe.k@chiba-u.jp

Recruiting

Feb. 05, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

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 or patients for whom screening tests can be conducted using blood samples collected before starting glucocorticoids administration
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.

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.

Both

glucocorticoid-induced osteoporosis

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

glucocorticoid-induced osteoporosis

dihydroxy-vitamin D3

D010024

C118756

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

<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

+81-43-226-2616

Jan. 05, 2022

No

none