None listed
Conditions
Interventions
Drug :
Bonviva Plus TM (ibandronate sodium 150mg + cholecalciferol 240mg) 1 tablet, once/month
+ Cicibon (Calcium Carbonate) 500mg qd 2 tablets, once/day
D-mac (Cholecalciferol) 10mg 1 tablet, 6 tim
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Postmenopausal females who had surgery for thyroid cancer 2) Subjects within 3 years of starting TSH suppression therapy 3) Low bone density = In the central bone DXA scan A. The average of two or more of L-spine BMD (L1-4) is from -2.0 or less to -3.0 or more, or B. Femur neck or total hip BMD of -1.5 or less to -2.5 or more 4) High-risk group of fractures are excluded. A. If there was an osteoporotic fracture within the last 3 years B. Fracture on L-S spine X-ray 5) When 1,2,3,4 are all satisfied
Exclusion criteria
Exclusion criteria: 1) Subjects who do not voluntarily consent to the clinical trial 2) Subjects with a history of receiving medication for osteoporosis within the last 2 years -Bisphosphonate-based drugs; Except for those who have been treated with osteoporosis drugs such as Posamax, Bonviva, Actonel, Maxmarville, Prolia (injection), Evista, etc. 3) Subjects with permanent hypoparathyroidism after surgery who require supplementation of over 1000mg of calcium and active vitamin D per day -active vitamin D: When bonky, calcitriol, onealfa (3 types) and calcium 1000mg (cicibon) are prescribed together for more than 1 year after surgery, it is considered as permanent hypoparathyroidism. 4) Subjects with bone metastasis cancer 5) Subjects who have been diagnosed with malignant tumors other than thyroid cancer within the last 5 years and are currently undergoing active treatment 6) Subjects with endocrine diseases that affect bone metabolism, such as Cushing's disease and hyperprolactinemia. 7) Subjects who used drugs that affect bone metabolism, such as steroids, bisphosphonates, and warfarin, excluding calcium and vitamin D within 6 months -The use of a combination of calcium/inactive vitD such as Dicamax, Cal-D, and Hard Cal, or a single drug of inactive vitamin D such as D-Mac is not included in the exclusion criteria. 8) Subjects with severe liver disease and severe kidney disease (CKD 3-4) 9) Subjects with severe (severe symptoms) hypercalcemia and subjects with severe (severe symptoms) hypercalciuria 10) Subjects with hyperparathyroidism or kidney stones 11) Subjects whose thyroid function is not controlled 12) Subjects with anacidosis or gastric acid deficiency 13) Pregnant or potentially pregnant women and lactating women 14) Subjects with serious comorbidities such as cardiovascular disease, chronic renal failure, and liver cirrhosis 15) Subjects with hypersensitivity reaction to the drug itself or other components of the drug used in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in absolute value of L-spine BMD after 48 weeks of treatment (% change between 0 and 48 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in absolute value of L-spine TBS and absolute value of hip BMD after 48 weeks of treatment;Changes in bone markers after 24 and 48 weeks of treatment: serum CTx, bone ALP, P1NP;Stability endpoint: Systemic malaise and side effects of digestive system disorders are evaluated using the attached questionnaire. Renal dysfunction: changes in serum Cr, Ca/P, and eGFR | — |
Countries
Korea, Republic of
Contacts
Public ContactSunWook Cho
Seoul National University Hospital
Outcome results
None listed