Conditions: Osteopenia
Keywords: Osteoporosis Osteopenia Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Salmon calcitonin Calcitonin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 129
Healthy volunteers: no

Brief summary:
The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture. The secondary purpose of this study was to determine if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets administered at dinner or at bedtime.

Detailed description:
This was a randomized, double-blind, placebo-controlled Phase 2 study conducted entirely in the US. The subjects were all post-menopausal women whose 10-year risk of major osteoporotic fracture was assessed using the World Health Organization (WHO) Fracture Risk Assessment Tool (FRAX®) algorithm within the first 3 visits. Eligible, consenting subjects were then enrolled and began a 2- week single-blind placebo run-in phase to determine tolerability. After the run-in phase, continuing subjects were randomized in a 2:1 ratio to receive oral calcitonin or placebo. All subjects took 600 mg calcium citrate and 1000 IU vitamin D once daily with breakfast beginning with the run-in phase. The duration of treatment including the run-in phase was 54 weeks. Bone mineral density (BMD) and C-terminal telopeptide of type 1 collagen (CTx-1) were determined at Baseline and Weeks 28 and 54 after randomization. The % change from baseline in lumbar spine BMD was calculated and compared: active to placebo. The change from baseline in plasma CTx-1 was also calculated and compared likewise.

To confirm that there is no effect of meal timing on this product, subjects in both arms were further randomized to take the active or placebo on an empty stomach at bedtime or with the meal at dinnertime.

Arms:
arm 1: Intervention: Oral calcitonin at dinnertime or oral calcitonin at bedtime. Postmenopausal subjects with osteopenia were treated for one year (also with vitamin D and calcium supplements) to determine if oral calcitonin tablets would prevent the loss of bone mineral density compared with placebo. Randomization to active or placebo was done 2:1. After randomization, further randomization was done to divide each arm into two groups, one in which dosing was at dinnertime and the other in which dosing was at bedtime to determine if food affected efficacy or safety. arm 2: Intervention: oral placebo at dinnertime or oral placebo at bedtime

Interventions: intervention 1: Oral calcitonin at dinnertime intervention 2: Oral placebo at dinnertime intervention 3: Oral calcitonin at bedtime intervention 4: Oral placebo at bedtime
Intervention descriptions: intervention 1: Oral calcitonin at dinnertime. intervention 2: Oral placebo at dinnertime. intervention 3: Oral calcitonin at bedtime intervention 4: Oral placebo at bedtime

Protocol document: