Choice of anti-osteoporotic therapy in postmenopausal women with type 2 diabetes mellitus at high risk of low trauma fractures.

Recruiting

• Conditions: Type 2 diabetes mellitus with other specified complications,

• Registration Number: CTRI/2022/02/039978
• Lead Sponsor: Postgraduate Institute of Medical Education and Research Chandigarh

Brief Summary

This study is a randomized, parallel group, multiple arm, single centered trial comparing the efficacy of teriparatide, zoledronate and denosumab, where every consecutive postmenopausal women diagnosed with type 2 DM attending  the endocrinology clinic at PGIMER, Chandigarh would be screened for possible inclusion in study. Those fulfilling the criteria would be randomized into 4 groups in 1:1:1:1 ratio. Group A (n=30) would receive injection teriparatide daily, Group B (n=30) would receive injection zoledronate 5mg once yearly, Group C (n=30) would receive injection denosumab 60mg every 6 months, along with calcium and vitamin D supplements. Group D (n=30) would receive only calcium and vitamin D supplements. The primary outcome would be to assess the percent change in BMD at lumbar spine and femoral neck and frequency of incident clinical major osteoporotic  and/or morphometric vertebral fragility fractures. Secondary outcomes will be to assess the change in BMD at distal radius, trabecular bone score, HR-pQCT (high-resolution peripheral quantitative computed tomography) parameters and bone turnover markers at the end of intervention and also to assess short-term change in glycemic control with anti-osteoporotic treatment.

Trial is open to recruitment and as of date, 27-08-2022, 88 participants have recruited with 22 participants in each group and we have been following them as mentioned in the protocol.

No serious adverse events noted so far.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-02
• Last Update Posted: 2022-08-27

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Ambulatory type 2 diabetes mellitus postmenopausal females 2.
• Age more than or equal to 50 years 3.
• Postmenopausal status for at least 5 years 4.
• Duration of type 2 diabetes mellitus at least 5 years 5.
• Baseline eGFR more than or equal to 45 ml/min/1.73 m2 6.
• Baseline HbA1c 7-10% 7.
• Prior vertebral (clinical or morphometric), hip, radius, humerus fragility fracture OR 9.
• Baseline BMD T-score at lumbar spine or femoral neck less than or equal to -2.5 (corrected for T2D) and baseline FRAX score (corrected for T2D) indicating a 10-year probability of hip fracture more than or equal to 2.5% or of major osteoporotic fracture more than or equal to 9%.
• Those willing to give informed consent.

Exclusion Criteria

• Type 1 diabetes mellitus or latent autoimmune diabetes in adults, or secondary diabetes mellitus 2.
• Prior history of use of bone-active therapies (bisphosphonates, teriparatide, denosumab, selective estrogen receptor modulators, hormone replacement therapies, calcitonin) 3.
• Prior history of glucocorticoid use at a dose more than or equal to 15 mg (prednisolone or equivalent) for more than or equal to 3 months.
• History of use of pioglitazone, thiazides, or canagliflozin over last 6 months 5.
• Hyperthyroidism (overt/subclinical) or overt hypothyroidism (detected during baseline screening) 6.
• History of hypoparathyroidism or primary hyperparathyroidism 7.
• History of acromegaly 8.
• History of Addison disease or Cushing’s syndrome 9.
• History of gonadal insufficiency (primary or secondary) 10.
• History of hypercalcemia (or detected during baseline screening) 11.
• Elevated hepatic transaminase levels more than or equal to 3 times upper limit of normal (detected during baseline screening) 12.
• Any solid organ or bone marrow transplant 13.
• History of any active or past malignancy 14.
• History of gastrointestinal disorders and malabsorption states, namely, celiac disease (also screened at baseline), inflammatory bowel disease, chronic hepatitis, bowel resection, chronic liver disease, gastrectomy, lactose intolerance 15.
• History of bone marrow related disorders, namely, leukemia, lymphoma, hemochromatosis, multiple myeloma (also screened at baseline), sarcoidosis, sickle cell anemia, thalassemia, amyloidosis 16.
• History of rheumatological disorders, namely, rheumatoid arthritis, ankylosing spondylitis, Marfans syndrome, Ehler-Danlos syndrome 17.
• History of any condition that may affect bone metabolism, namely, Paget’s disease, osteopetrosis, osteogenesis imperfecta, hypophosphatasia 18.
• History of recent tooth extraction (within 6 months of screening).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the percent change in BMD at the lumbar spine and femoral neck at the end of intervention	18 months
2. To assess the frequency of incident clinical major osteoporotic fractures (fragility) and/or morphometric vertebral fractures (fragility) during intervention	18 months

Secondary Outcome Measures

Name	Time	Method
1. To assess the percent change in BMD at the 33% radius at the end of intervention	2. To assess the change in trabecular bone score (TBS) at the end of intervention

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Postgraduate Institute of Medical Education and Research

🇮🇳Chandigarh, CHANDIGARH, India

Dr Rimesh Pal

Principal investigator

8727053344

rimesh.ben@gmail.com