Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol

Osteoporosis Clinical Trial

— e-GLORIA  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974167
• Other study ID #: 2013/9/9 Ver1.0
• Secondary ID: UMIN000011700
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2013
• Last updated: August 5, 2014
• Start date: December 2013

Study information

• Verified date: May 2014
• Source: e-GLORIA trial Protocol Review Committee
• Contact: e-GLORIA trial Office
• Phone: +81-6229-8937
• Email: e-gloria[@]mebix.co.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis, using a randomized, open-label, parallel-group, comparative design.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• (1) Patients who are currently taking or plan to take oral glucocorticoid medication for 3 months or longer and thus require treatment as per the 'Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and mineral Research (2004),' and who meet at least one of the conditions below. No restriction is imposed on the underlying disease treated with the oral glucocorticoid medication.

(i) Have any existing insufficiency fracture (ii) %YAM <80 (iii) Oral glucocorticoid daily dose >= 5 mg prednisolone equivalent

• (2) Aged between 20 and 85 years (both inclusive) at consent

• (3) Patients who are able to walk without assistance

• (4) Provided consent to participate in the study

Exclusion Criteria:

• (1) BMD (L1-4 or T-Hip) T score < -3.5

• (2) Have 3 or more vertebral fractures between L1 and L4.

• (3) Have 1 or more SQ grade 3 vertebral fractures, or 3 or more SQ grade 2 vertebral fractures.

• (4) Have received a bisphosphonate preparation for 2 weeks or longer within 6 months before the start of study treatment.

• (5) Have received a bisphosphonate preparation for 2 years or longer within 3 years before the start of study treatment.

• (6) Have received a parathyroid hormone preparation before the start of study treatment.

• (7) Have received one or more doses of an anti-RANKL (receptor activator of nuclear factor-kappa B ligand) antibody.

• (8) Have received one or more doses of an anti-sclerostin antibody or cathepsin K inhibitor.

• (9) Have received any other investigational product (including placebo) within 16 weeks before the start of study treatment in the present study.

• (10) Have received any of the following drugs that can affect bone metabolism within 8 weeks before the start of study treatment, with the exception of calcium preparations: (i) Bisphosphonates (ii) Active vitamin D preparations (including those for topical use) (iii) Selective estrogen receptor modulators (SERMs) (iv) Calcitonin preparations (v) Vitamin K2 preparations (vi) Ipriflavone preparations (vii) Reproductive hormone products (except those for vaginal use such as vaginal tablets and creams) (viii) Other drugs that can affect bone metabolism

• (11) Pregnant woman or woman who desires to become pregnant

• (12) Have corrected serum calcium >= 10.4 mg/dL or < 8.0 mg/dL at enrollment.

• (13) Have corrected urinary calcium > 0.4 mg/dL GF at enrollment.

• (14) Have a past or current history of urinary calculus.

• (15) Have eGFR < 30 mL/min/1.73 m2 at enrollment.

• (16) Have severe liver disease such as cirrhosis or severe heart disease such as severe cardiac failure.

• (17) Have active malignancy or received treatment for malignancy, including adjuvant therapy, within the past 3 years.

• (18) Have a history of hypersensitivity to eldecalcitol, alfacalcidol, or other vitamin D preparations.

• (19) Other persons judged by the investigator (or subinvestigator) to be inappropriate to participate in this study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Eldecalcitol
Eldecalcitol 0.75 microgram once daily orally
• Alfacalcidol
Alfacalcidol 1 microgram once daily orally

Locations

Country	Name	City	State
Japan	Nara Hospital Kinki University Faculty of Medicine	Ikoma	Nara

Sponsors (1)

Lead Sponsor	Collaborator
e-GLORIA trial Protocol Review Committee

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in lumbar spine (L1-4) bone mineral density		12 months after the start of study drug administration	No
Primary	Incidence of vertebral fractures	A vertebral fracture will be classified as a new fracture (i.e., change from grade 0 to grade 1, 2, or 3) or worsening of a prevalent fracture (i.e., change from grade 1 to grade 2 or 3, or change from grade 2 to grade 3) using a semi-quantitative [SQ] method according to the "Vertebral Fracture Assessment Criteria, 2012 revised version."	36 months	No
Secondary	Incidence of non-vertebral fractures (both traumatic and non-traumatic; All sites)		36 months	No
Secondary	Incidence of non-vertebral fractures (both traumatic and non-traumatic; 3 Major sites)	The 3 Major sites are defined as the forearm, humerus, and femur.	36 months	No
Secondary	Incidence of non-vertebral fractures (both traumatic and non-traumatic; 6 Major sites)	The 6 Major sites are defined as the femur, lower leg, humerus, forearm, clavicle, and pelvis.	36 months	No
Secondary	Incidence of non-vertebral fractures (traumatic; All sites)		36 months	No
Secondary	Incidence of non-vertebral fractures (traumatic; 3 Major sites)		36 months	No
Secondary	Incidence of non-vertebral fractures (traumatic; 6 Major sites)		36 months	No
Secondary	Incidence of non-vertebral fractures (non-traumatic; All sites)		36 months	No
Secondary	Incidence of non-vertebral fractures (non-traumatic; 3 Major sites)		36 months	No
Secondary	Incidence of non-vertebral fractures (non-traumatic; 6 Major sites)		36 months	No
Secondary	Incidence of vertebral fractures (new vertebral fractures)		36 months	No
Secondary	Incidence of vertebral fractures (worsening of prevalent vertebral fractures)		36 months	No
Secondary	Incidence of vertebral fractures (clinical vertebral fractures)		36 months	No
Secondary	Incidence of vertebral fracture (new or worsening of prevalent fractures) by glucocorticoid dose		36 months	No
Secondary	Incidence of clinical vertebral fractures by glucocorticoid dose		36 months	No
Secondary	Incidence of non-vertebral fractures (all sites) by glucocorticoid dose		36 months	No
Secondary	Incidence of non-vertebral fractures (3 Major sites) by glucocorticoid dose		36 months	No
Secondary	Incidence of non-vertebral fractures (6 Major sites) by glucocorticoid dose		36 months	No
Secondary	Incidence of vertebral fractures (new or worsening) by bone mineral density		36 months	No
Secondary	Incidence of clinical vertebral fractures by bone mineral density		36 months	No
Secondary	Incidence of non-vertebral fractures (all sites) by bone mineral density		36 months	No
Secondary	Incidence of non-vertebral fractures (3 Major sites) by bone mineral density		36 months	No
Secondary	Incidence of non-vertebral fractures (6 Major sites) by bone mineral density		36 months	No
Secondary	Incidence of vertebral fractures (new or worsening) by number of prevalent fractures		36 months	No
Secondary	Incidence of clinical vertebral fractures by number of prevalent fractures		36 months	No
Secondary	Incidence of non-vertebral fractures (all sites) by number of prevalent fractures		36 months	No
Secondary	Incidence of non-vertebral fractures (3 Major sites) by number of prevalent fractures		36 months	No
Secondary	Incidence of non-vertebral fractures (6 Major sites) by number of prevalent fractures		36 months	No
Secondary	Incidence of new vertebral fractures by severity	Semiquantitative (SQ) method is used for grading of vertebral fractures.	36 months	No
Secondary	Incidence of new clinical vertebral fractures by severity	SQ method is used for grading of vertebral fractures.	36 months	No
Secondary	Incidence of new non-vertebral fractures (all sites) by severity	SQ method is used for grading of vertebral fractures.	36 months	No
Secondary	Incidence of new non-vertebral fractures (3 Major sites) by severity	SQ method is used for grading of vertebral fractures.	36 months	No
Secondary	Incidence of new non-vertebral fractures (6 Major sites) by severity		36 months	No
Secondary	Incidence of osteoporotic fractures	An osteoporotic fracture is defined as a fracture of the following sites: vertebral body, ribs, pelvis, humerus, clavicle, scapula, sternum, proximal femur, other portions of the femur, tibia, fibula, and forearm.	36 months	No
Secondary	Incidence of FRAX-defined major osteoporotic fractures	The 4 Major sites are defined as clinical fractures of the spine, forearm, hip, and shoulder.	36 months	No
Secondary	Percent change in lumbar spine bone mineral density		6 months after the start of study drug administration	No
Secondary	Percent change in lumbar spine bone mineral density		24 months after the start of study drug administration	No
Secondary	Percent change in lumbar spine bone mineral density		36 months after the start of study drug administration (or at the time of withdrawal from the study)	No
Secondary	Change in proximal femur (total-hip) bone mineral density		6 months after the start of study drug administration	No
Secondary	Change in proximal femur (total-hip) bone mineral density		12 months after the start of study drug administration	No
Secondary	Change in proximal femur (total-hip) bone mineral density		24 months after the start of study drug administration	No
Secondary	Change in proximal femur (total-hip) bone mineral density		36 months after the start of study drug administration (or at the time of withdrawal from the study)	No
Secondary	Percent change in TRACP-5b bone metabolism marker		6 months after the start of study drug administration	No
Secondary	Percent change in TRACP-5b bone metabolism marker		12 months after the start of study drug administration	No
Secondary	Percent change in PINP bone metabolism marker		6 months after the start of study drug administration	No
Secondary	Percent change in PINP bone metabolism marker		12 months after the start of study drug administration	No
Secondary	Frequency of falls		36 months	No
Secondary	Change in muscle strength (back muscle strength)		12 months after the start of study drug administration	No
Secondary	Change in muscle strength (back muscle strength)		24 months after the start of study drug administration	No
Secondary	Change in muscle strength (back muscle strength)		36 months after the start of study drug administration (or at the time of withdrawal from the study)	No
Secondary	Change in muscle strength (grip strength)		12 months after the start of study drug administration	No
Secondary	Change in muscle strength (grip strength)		24 months after the start of study drug administration	No
Secondary	Change in muscle strength (grip strength)		36 months after the start of study drug administration (or at the time of withdrawal from the study)	No
Secondary	Change in height		12 months after the start of study drug administration	No
Secondary	Change in height		24 months after the start of study drug administration	No
Secondary	Change in height		36 months after the start of study drug administration (or at the time of withdrawal from the study)	No