Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis (DIOS)

Alvogen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Women With Osteoporosis

Treatments: Drug: Test group; Drug: Reference group

Study type: Interventional

Funder types: Industry

Identifiers

NCT01581320

DP-CTR206-03

Details and patient eligibility

About

A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.

Enrollment: 201 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female more than 40 years old in postmenopausal

Exclusion criteria

• Subject who has a history of malignant cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

201 participants in 2 patient groups

DP-R206

Experimental group

Treatment:

Drug: Test group

Bonviva

Active Comparator group

Treatment:

Drug: Reference group