{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:19:10Z","timestamp":1777879150982,"version":"3.51.4"},"reference-count":24,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2023,1,1]],"date-time":"2023-01-01T00:00:00Z","timestamp":1672531200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Indian Society for Bone & Mineral Research"},{"name":"Endocrine Society of India","award":["RG1-2022"],"award-info":[{"award-number":["RG1-2022"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Endocrinology"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>People with type 2 diabetes (T2D) are at high risk of fragility fractures; however, there are no randomized controlled trials evaluating the efficacy of anti-osteoporosis drugs as a primary pre-specified endpoint in T2D.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To compare the efficacy of anti-osteoporotic drugs in postmenopausal women with T2D.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>Prospective, randomized, open, blinded endpoint clinical pilot trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      Postmenopausal women (\u2a7e50\u2009years) with T2D (duration \u2a7e5\u2009years), HbA1c 7\u201310%, eGFR \u2a7e45\u2009mL\/min\/1.73\u2009m\n                      <jats:sup>2<\/jats:sup>\n                      and prior vertebral (clinical\/morphometric), hip, radius, humeral fragility fracture or bone mineral density (BMD) T-score (adjusted for diabetes) at lumbar spine\/femoral neck \u2a7d\u22122.5 and high FRAX score will be eligible for inclusion. Subjects with secondary causes of osteoporosis, prior exposure to bone-active therapies or history of use of glucocorticoids\/pioglitazone\/thiazides\/canagliflozin will be excluded. Finally, eligible subjects will undergo estimation of serum calcium, phosphate, alkaline phosphatase, parathyroid hormone, 25-hydroxyvitamin D and bone turnover markers (BTMs) (total procollagen type I N-propeptide, \u03b2-CTX) along with trabecular bone score (TBS) and high-resolution peripheral quantitative computed tomography (HR-pQCT) of non-dominant hand and leg. After a 2-week run in phase, they will be randomized in a 1:1:1:1 ratio to receive yearly zoledronate, or biannually denosumab or daily teriparatide (in addition to standard of care, i.e., calcium 1000\u2009mg\/day and cholecalciferol 1000\u2009IU\/day) or only standard of care (control). The primary endpoints will be change in areal BMD and frequency of incident fractures at 18\u2009months. The secondary endpoints will be change in HR-pQCT parameters, TBS and BTMs at 18\u2009months. Adverse events will be recorded for all randomized participants.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics:<\/jats:title>\n                    <jats:p>The study has been approved by the Institute Ethics Committee. Written informed consent will be obtained from each participant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>The trial is expected to provide information regarding optimal anti-osteoporotic therapy in people with T2D and bone fragility.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration:<\/jats:title>\n                    <jats:p>Prospectively registered in Clinical Trial Registry of India (CTRI\/2022\/02\/039978).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20420188231207516","type":"journal-article","created":{"date-parts":[[2023,10,21]],"date-time":"2023-10-21T07:27:10Z","timestamp":1697873230000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["Efficacy of zoledronate, denosumab or teriparatide in postmenopausal women with type 2 diabetes mellitus at high risk of fragility fractures: protocol of an open, blinded endpoint randomized controlled pilot trial"],"prefix":"10.1177","volume":"14","author":[{"given":"Trupti Nagendra","family":"Prasad","sequence":"first","affiliation":[{"name":"Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjay Kumar","family":"Bhadada","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veenu","family":"Singla","sequence":"additional","affiliation":[{"name":"Department of Radiodiagnosis and Imaging, Postgraduate Institute of Medical Education and Research, Chandigarh, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neelam","family":"Aggarwal","sequence":"additional","affiliation":[{"name":"Department of Gynaecology and Obstetrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sant","family":"Ram","sequence":"additional","affiliation":[{"name":"Department of Biochemistry, Postgraduate Institute of Medical Education and Research, Chandigarh, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uttam Chand","family":"Saini","sequence":"additional","affiliation":[{"name":"Department of Orthopaedics, Postgraduate Institute of Medical Education and Research, Chandigarh, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashok","family":"Kumar","sequence":"additional","affiliation":[{"name":"National Institute of Nursing Education (NINE), Postgraduate Institute of Medical Education and Research, Chandigarh, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4859-9393","authenticated-orcid":false,"given":"Rimesh","family":"Pal","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, 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