title: A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal women with osteoporosis.
abstract: BACKGROUND
  Osteoporosis is a serious condition affecting up to 50% of Indian postmenopausal women. Denosumab reduces bone resorption by targeting the receptor activator of nuclear factor-κB ligand. This study assessed the efficacy and safety of denosumab in Indian postmenopausal women with osteoporosis.
  
  
  METHODS
  In this double-blind, multicenter, phase 3 study, 250 Indian postmenopausal women aged 55 to 75 years (T-score <-2.5 and >-4.0 at the lumbar spine or total hip; serum 25(OH) D levels ≥20 ng/mL) were randomized to receive one subcutaneous dose of denosumab 60 mg or placebo. All subjects received oral calcium ≥1000 mg and vitamin D3 ≥ 400 IU daily. The primary end point was mean percent change in bone mineral density (BMD) at the lumbar spine from baseline to Month 6. Secondary end points included mean percent change from baseline in BMD at total hip, femoral neck, and trochanter at Month 6 and median percent change from baseline in bone turnover markers at Months 1, 3, and 6.
  
  
  RESULTS
  Total 225 subjects (denosumab = 111, placebo = 114) completed the six-month study. Baseline demographics were similar between groups. A 3.1% (95% confidence interval, 1.9%, 4.2%) increase favoring denosumab versus placebo was seen for the primary end point (P < 0.0001). Denosumab demonstrated a significant treatment benefit over placebo for the secondary end points. There were no fractures or withdrawals due to adverse events.
  
  
  CONCLUSIONS
  Consistent with results from studies conducted in other parts of the world, denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a six-month period in Indian postmenopausal women.
authors.affiliation: Pitale Diabetes and Hormone Centre, Nagpur, Maharashtra, India.
authors.forename: Shailesh
authors.initials: S
authors.lastname: Pitale
authors.affiliation: Health and Research Centre, Trivandrum, Kerala, India.
authors.forename: Mathew
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Rathi Hospital and Research Centre, Ahmedabad, Gujarat, India.
authors.forename: Gaurav
authors.initials: G
authors.lastname: Rathi
authors.affiliation: Deshmukh Clinic and Research Centre, Pune, Maharashtra, India.
authors.forename: Vaishali
authors.initials: V
authors.lastname: Deshmukh
authors.affiliation: Bangalore Diabetes Hospital, Bangalore, India.
authors.forename: Prasanna
authors.initials: P
authors.lastname: Kumar
authors.affiliation: Medisys Clinisearch India, Bangalore, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Reddy
authors.affiliation: M. S. Ramaiah Clinical Research Center, Bangalore, Karnataka, India.
authors.forename: Naresh
authors.initials: N
authors.lastname: Shetty
authors.affiliation: Department of Medicine, Sir Ganga Ram Hospital, New Delhi, India.
authors.forename: Atul
authors.initials: A
authors.lastname: Kakar
authors.affiliation: Sushrut Hospital Research Centre, Nagpur, Maharashtra, India.
authors.forename: Sushrut
authors.initials: S
authors.lastname: Babhulkar
authors.affiliation: Centre for Knee and Hip Surgery, Vadodara, Gujarat, India.
authors.forename: Bharat
authors.initials: B
authors.lastname: Mody
authors.affiliation: Father Muller Medical College, Mangalore, Karnataka, India.
authors.forename: Jacob
authors.initials: J
authors.lastname: Chacko
authors.affiliation: GlaxoSmithKline, Mumbai, Maharashtra, India.
authors.forename: Sudeep
authors.initials: S
authors.lastname: Acharya
authors.affiliation: GlaxoSmithKline, Mumbai, Maharashtra, India.
authors.forename: Sadhna
authors.initials: S
authors.lastname: Joglekar
authors.affiliation: GlaxoSmithKline, Mumbai, Maharashtra, India.
authors.forename: Vipul
authors.initials: V
authors.lastname: Halbe
authors.affiliation: GlaxoSmithKline, King of Prussia, Pennsylvania, USA.
authors.forename: Barbara G
authors.initials: BG
authors.lastname: Kravitz
authors.affiliation: GlaxoSmithKline, King of Prussia, Pennsylvania, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Waterhouse
authors.affiliation: GlaxoSmithKline, King of Prussia, Pennsylvania, USA.
authors.forename: Antonio J
authors.initials: AJ
authors.lastname: Nino
authors.affiliation: GlaxoSmithKline, King of Prussia, Pennsylvania, USA.
authors.forename: Lorraine A
authors.initials: LA
authors.lastname: Fitzpatrick
keywords: Bone mineral density; India; bone turnover markers; denosumab; osteoporosis; postmenopausal