Trials Sponsors Conditions Drugs Pricing

Conditions

Low Bone Mineral Density Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Baseline to 12 months

Secondary Outcomes (10)

Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine
Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Total Hip
Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Femoral Neck
Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Total Hip
Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Femoral Neck
Baseline to 12 months
+5 more secondary outcomes

Study Arms (2)

Eldecalcitol

EXPERIMENTAL

Participants receive oral eldecalcitol 0.75μg daily for 12 months

Drug: Eldecalcitol capsules

Calcitriol

ACTIVE COMPARATOR

Participants receive oral calcitriol 0.5μg daily for 12 months

Drug: Calcitriol capsules

Interventions

Eldecalcitol capsulesDrug

Oral eldecalcitol 0.75μg daily

Also known as: Edirol

Eldecalcitol

Calcitriol capsulesDrug

Oral calcitriol 0.5μg daily

Also known as: Haidewei

Calcitriol

Eligibility Criteria

Age50 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Postmenopausal women (based on medical history) aged 50 or older and menopause time more than 2 years. If there is uncertainty regarding menopausal status, women 60 years of age and older will be considered postmenopausal.
BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening:

Sponsors & Collaborators

Chugai Pharma China Co., Ltd.
Type not reportedcollaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Otherlead

Study Sites (21)

The Second Xiangya Hospital of Central South University

Changsha, China

COMPLETED

Zhejiang Provincial People's Hospital

Hangzhou, China

COMPLETED

The Fourth Affiliated Hospital of Harbin Medical University

Ha’erbin, China

RECRUITING

Zhifeng ChengCONTACT

Zhifeng Cheng

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosis, Postmenopausal

Interventions

eldecalcitolCalcitriol

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesOsteoporosis

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferol

Study Officials

Zhenlin Zhang
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Shen

CONTACT

(+86)15800674978 shenli_0510@126.com

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Chief Physician

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 13, 2023

Study Start

September 27, 2023

Actual (reported)

Primary Completion

June 2025

Estimated (date passed)

Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Eldecalcitol

Calcitriol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Eldecalcitol

Calcitriol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations