A PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF ODANACATIB (MK-0822) IN THE TREATMENT OF MEN WITH OSTEOPOROSIS TREATED WITH VITAMIN D AND CALCIUM

Not Applicable

• Conditions: -M815; M815

• Registration Number: PER-045-10
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 0

Inclusion Criteria

• The patient is a man between 40 and 95 years old on the day of Randomization.
• The patient has idiopathic osteoporosis or osteoporosis due to hypogonadism
• The patient has a lumbar spine anatomy suitable for DXA. Specifically, at least 2 vertebral bodies in the Ll to L4 region must be evaluable (the patient must not have significant sclerosis, degenerative arthropathy, bone trauma, or sequelae or instruments for traumatology (hardware) as a result of orthopedic procedures).
• The patient understands the study procedures, available alternative treatments, risks involved in the study, and voluntarily agrees to participate by providing written informed consent.
• The patient is outpatient.
• The patient can read, understand and fill out questionnaires and diaries

Exclusion Criteria

• The patient has chosen a treatment with oral bisphosphonate or other agents for the treatment of osteoporosis.
• The patient has had a fracture due to previous clinical fragility of the hip, and is a suitable candidate for osteoporosis therapy (ie bisphosphonates, parathyroid hormone (PTH)).
• The patient has presented a clinical fragility fracture (including a vertebral fracture) within 12 months, documented by medical history or detected on the spinal radiographs of the selection read locally, unless the patient is not willing to take a commercialized therapy for osteoporosis or not be a candidate for it.
• The patient has had more than 1 anterior vertebral fracture (defined as loss of anterior, middle or posterior height> 20%) and is a suitable candidate for osteoporosis therapy (ie bisphosphonates or PTH).
• The patient has or has had evidence of a metabolic bone disorder other than osteoporosis.
• The patient has vitamin D deficiency, which is defined as serum 25-hydroxyvitamin D <15 ng / ml. If patients with vitamin D deficiency are otherwise eligible for the study, they can be selected again once adequate vitamin D replacement has been performed.
• The patient has a history of kidney stones, and serum calcium, serum 25-hydroxyvitamin D and serum PTH are not all within normal limits, as measured by the central laboratory.
• The patient has an active parathyroid disease. (Note: The level of serum PTH should be evaluated in the selection in the case of patients with a documented history of parathyroid disease. Patients with a history of primary hyperparathyroidism and therapeutic parathyroidectomy> 2 years before selection are not excluded).
• The patient has an abnormal level of TSH (as measured by the central laboratory). The central laboratory can repeat the TSH measurement once during the selection period. Enrollment will be based on the repeated value of the TSH. If the repeated value of TSH is of the upper limit of normal in a participant with known hypothyroidism, he is eligible as long as 110 changes in thyroxine replacement are required. Patients with abnormal TSH level who are receiving a thyroid drug (antithyroid drug or thyroxine replacement), can be selected again after treatment has been adjusted and the patient´s condition has been stabilized (defined by a normal level of TSH of at least 6 weeks after the change in the drug). Patients with newly diagnosed thyroid conditions are not eligible.
• The patient has a serum creatinine level> 1.6 mg / dL and is considered to have severe renal insufficiency that is defined as the calculation of creatinine clearance <29 ml / min (K / DOQI Guidelines of the National Kidney Foundation ).
• The patient has secondary osteoporosis due to celiac disease, malabsorption, rheumatoid arthritis, systemic inflammatory disease, mastocytosis or HIV infection.
• The patient has a daily calcium intake of <1,200 mg and is not willing to take the supplements prescribed in the study or increase dietary intake, so that his daily calcium intake is at least 1200 mg
• The patient has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that could cause confusion in the results of the study, or interfere with the patient´s participation throughout the study, so that it

Study & Design

• Study Type: Interventional
• Study Design: Not specified