Post-menopausal Women Osteoporosis(Phase III)

Hanlim Pharm

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Women Osteoporosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01806792

HL_RSNPM_301

Details and patient eligibility

About

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

Full description

The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.

Enrollment: 150 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

1. women osteoporosis
2. 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
3. low levels of 25(OH)D > 9 ng/mL
4. patients who give written consent of agreement to voluntarily participate in the clinical study
5. patients who can read and understand written instructions

Exclusion criteria

1. patients who had contraindications to oral bisphosphonates, such as esophageal strictures
2. ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
3. low levels of 25(OH)D (less than 9 ng/mL).
4. 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.
5. drug administration after diagnosing as alcoholic or psychical disease
6. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Risendronate and Cholecalciferol combination

Experimental group

Description:

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

Treatment:

Drug: Placebo(for Risedronate)

Drug: risedronate combine

Risedronate

Active Comparator group

Description:

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

Treatment:

Drug: Risedronate

Drug: Placebo(for risedronate combine)