Post-menopausal Women Osteoporosis(Phase III)

NCT01806792 | Completed Phase 3

• 1 other identifier: HL_RSNPM_301
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis

Conditions

Postmenopausal Women Osteoporosis

Keywords

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.

  16 weeks form first drug adminstration.

Secondary Outcomes (1)

• proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.

  16 weeks form first drug administration.

Study Arms (2)

Risendronate and Cholecalciferol combination

EXPERIMENTAL

risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month.

Drug: risedronate combine; Drug: Placebo(for Risedronate)

Risedronate

ACTIVE COMPARATOR

risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month.

Drug: Risedronate; Drug: Placebo(for risedronate combine)

Interventions

risedronate combine DRUG

Also known as: - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined)

Risendronate and Cholecalciferol combination

Risedronate DRUG

Also known as: Other name : Actonel(Risedronate 150mg)

Risedronate

Placebo(for Risedronate) DRUG

Also known as: once a month

Risendronate and Cholecalciferol combination

Placebo(for risedronate combine) DRUG

Also known as: once a month

Risedronate

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• women osteoporosis
• patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of \< -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of \< -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level \> 40 IU/L, with a reported hysterectomy
• low levels of 25(OH)D \> 9 ng/mL
• patients who give written consent of agreement to voluntarily participate in the clinical study
• patients who can read and understand written instructions

You may not qualify if:

• patients who had contraindications to oral bisphosphonates, such as esophageal strictures
• ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
• low levels of 25(OH)D (less than 9 ng/mL).
• Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of \> 200 IU.
• drug administration after diagnosing as alcoholic or psychical disease
• patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Chung-ang university hospital

Seoul, 156-755, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Cholecalciferol; Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hyoung-Moo Park, MD

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 7, 2013
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

KR (1)