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The effect of calcium, Vitamin D, and denosumab on osteoporosis and basal metabolism in postmenopausal diabetic women

The effect of calcium, Vitamin D, and denosumab on osteoporosis and basal metabolism in postmenopausal diabetic women - The effect of denosumab on basal metabolism in type 2 diabetic women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023292
Enrollment
50
Registered
2016-07-22
Start date
2015-03-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus, Osteoporosis

Interventions

Calcium / Vitamin D / Magnesium mixed tablet
Calcium 305mg, Cholecalciferol 0.005mg (200IU), Magnesium carbonate 59.2mg is containing per tablet. Taking 2 tablet / day prior 1 month from Denosumab 60mg injection to subcutaneous, once per 6 month

Sponsors

Tokyo Women's Mediclcal University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient of type 2 Diabetes Mellitus 1: More than 50 years of age at the time of obtaining informed consent 2:With osteoporosis 3: At the participation in this study, that document consent is obtained due to free will of the patient's own by sufficient explanation and thorough understanding. 4:Control of blood pressure and blood glucose are relatively stable, and without planning for remarkable change.

Exclusion criteria

Exclusion criteria: The patients who Taking drug for osteoporosis With presence and past history of malignancy. With other endocrine diseases With liver dysfunction except fatty liver With macro proteinuria or with increased serum creatinine level over 2.0mg/dl Principal investigator of this study has determined to be inappropriate as a subject

Design outcomes

Primary

MeasureTime frame
Changes of the Basal metabolism, and the marker of the bone metabolism before and after taking Calcium/Vitamin D and denosumab

Secondary

MeasureTime frame
Changes of the blood glucose control level, fasting CPR, iPTH, 25hydroxyvitamin D, blood cell count, serum calcium, phosphate and other general examination of blood, and diabetic neuropathy

Countries

Japan

Contacts

Public ContactMakiko Ogata

Tokyo Women's Medical University Diabetes Center

mogatamd.dmc@twmu.ac.jp03-3353-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026