Extension to the Odanacatib Fracture Trial (PN018)

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2014-002587-33-GB
• Date of registration: 02/12/2014
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
• Public title: Extension to the Odanacatib Fracture Trial (PN018)
• Scientific title: An Open-Label 5-Year 2nd Extension to: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium - Open-Label Extension to the Odanacatib Fracture Trial (PN018)
• Date of first enrolment: 22/01/2015
• Target sample size: 5000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002587-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Estonia, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Lithuania, Mexico, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom

Contacts

• Name: Global Clinical Trials Operations
• Affiliation: Merck Sharp & Dhome Corp.

• Name: Global Clinical Trials Operations
• Affiliation: Merck Sharp & Dhome Corp.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have met all initial inclusion criteria and have not met any of the exclusion or
discontinuation criteria of either the base or 1st extension studies.
2. Be an active participant and have successfully completed the 1st extension study on study medication. (Note: An interruption of approximately 12 weeks from the end of 1st extension study to the beginning of 2nd extension study is permissible).
3. Be assessed by the investigator as having had appropriate compliance during the base and 1st extension studies.
4. Have at least one hip (e.g., contains no hardware from orthopedic procedures) AND
suitable spinal anatomy that is evaluable by DXA.
5. Understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agree to participate by providing informed consent.
6. Be able to read, understand and complete questionnaires and diaries.
7. Be in generally good health, based on medical history, physical examination, and
laboratory evaluation.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5000

Exclusion criteria:
The subject must be excluded from participating in the trial if the subject:
1. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
2. Is receiving treatment as follows:
1) Current use of osteoporosis therapy including: bisphosphonates, PTH, strontium, systemic estrogen + progestin, raloxifene or other SERM, RANK ligand inhibitor, or sub-cutaneous calcitonin. (Note: use of intranasal calcitonin is permitted.)
2) Subject is planning to initiate or is currently using long-term therapy (6 weeks
or longer) with any CYP3A4 inducers (see Appendix 12.5 for examples).
3. Is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or the subject cannot read or comprehend the
written material.
4. Has participated in an investigational drug study other than the base study or 1st extension study within the past 30 days.
5. Is currently a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

osteoporosis
MedDRA version: 17.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Odanacatib
Product Code: MK-0822
Pharmaceutical Form: Tablet
INN or Proposed INN: Odanacatib
CAS Number: 603139-19-1
Current Sponsor code: MK-0822
Other descriptive name: ODANACATIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: In postmenopausal women with osteoporosis previously treated with odanacatib 50 mg once-weekly for at least 5 years:
(1) To assess long-term changes from baseline in bone mineral density (BMD) of lumbar spine, femoral neck (top of thigh), and trochanter (thigh bone) after 10 years of odanacatib treatment
(2) To determine the incidence of morphometrically assessed vertebral fractures during 10 years of odanacatib treatment. Morphometrically assessed fractures are typically crushed vertebrae which are seen on spine X-ray but which generally do not cause any symptoms.
(3) To determine the incidence of all clinical fractures during 10 years of odanacatib treatment. In postmenopausal women with osteoporosis previously treated with placebo for at least 5 years and then switched to open-label odanacatib 50 mg once-weekly:
(4) To assess changes from baseline in BMD of lumbar spine, total hip, femoral neck, and trochanter during 5 years of odanacatib treatment
(5) To determine the inc

Main Objective: (1) to assess long-term changes from baseline in total hip bone mineral density (BMD) after 10 years of treatment with odanacatib 50 mg once-weekly in postmenopausal osteoporotic women previously treated with once-weekly odanacatib for at least 5 years
(2) to assess safety and tolerability of long-term treatment with odanacatib 50 mg once-weekly.

Primary end point(s): Percent change from baseline in total hip bone mineral density (BMD) up to the end of the extension study

Timepoint(s) of evaluation of this end point: At end of study (2019)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At end of study (2019)

Secondary end point(s): Percent change from baseline in lumbar spine, femoral neck and trochanter (parts of the hip and thigh) bone mineral density (BMD) up to the end of the extension;
Percent change from start of open-label (Year 6) in lumbar spine, total hip, femoral neck and trochanter BMD up to the end of the extension study;
Time to first morphometric fracture (fracture detected by and X-ray, rather than by symptoms);
Time to first clinical fracture (vertebral and non-vertebral).Vertebral fractures are fractures of the spine whereas non-vertebral fractures are non-spine fractures, For the purposes of this study, non-vertebral fractures exclude fractures of the fingers, toes, face, and skull.

Secondary ID(s)

MK-0822-018

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 24/07/2019
• Date Completed: 01/02/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002587-33/results