Phase 4 N=1,053 Randomized Treatment

Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT01675297 ↗

Enrolled (actual)

1,053

Serious AEs

7.6%

Results posted

Aug 2019

Primary outcome: Primary: The Change of Bone Mineral Density (BMD) Value — 0.77; 0.77; 0.81; 0.80 g/cm^2

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Risedronate/Cholecalciferol combination (Drug); Risedronate (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Hanlim Pharm. Co., Ltd.
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY The Change of Bone Mineral Density (BMD) Value	0.77; 0.77; 0.81; 0.80; 0.04; 0.03	—
SECONDARY The Change of 25OHD(25-hydroxyvitamin D)	18.23; 17.83; 28.93; 19.47; 30.57; 18.35	—
SECONDARY PTH(Parathyroid Hormone Value)	40.48; 39.17; 37.34; 42.40; 39.17; 45.27	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Male osteoporosis patients over 19 years of age
Female osteoporosis patients with menopause
Definition of osteoporosis
They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral neck or total. Or evidence of at least one vertebral fracture
Definition of menopause(can be one of three condition)
For 12months spontaneous amenorrhea
For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40mlU/mL and over
6weeks after bilateral ovariectomy whether hysterectomy or not.

Exclusion Criteria

Patients with esophagus disorder (i.e:esophagostenosis)
Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
Patients with serum calcium concentrations 8.0mg under
Patients with severe nephropathy (CCr 30mL/min less)
Patients with unable to sit upright or stand for 30minutes

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01675297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.