# Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

> **NCT01631214** · PHASE3 · COMPLETED · sponsor: **Amgen** · enrollment: 4093 (actual)

## Conditions studied

- Postmenopausal Women With Osteoporosis

## Interventions

- **BIOLOGICAL:** Romosozumab
- **DRUG:** Alendronate
- **DRUG:** Placebo to Romosozumab
- **DRUG:** Placebo to Alendronate

## Key facts

- **NCT ID:** NCT01631214
- **Lead sponsor:** Amgen
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-05-04
- **Primary completion:** 2017-02-27
- **Final completion:** 2017-06-29
- **Target enrollment:** 4093 (ACTUAL)
- **Last updated:** 2025-02-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01631214

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01631214, "Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT01631214. Licensed CC0.

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