Denosumab 60 mg subcutaneously injection with prefilled syringe

NaCl 0.9%, 20ml phial, solution for injection

Osteoporosis

Systemic Mastocytosis

Each subcutaneous injection will occur every 6 months during 3 years for a total of 7 injections

Denosumab

Placebo

Jean Minjoz Hospital, Dermatology department

Caen Hospital, Clinical haematology department

Estaing Hospital, Cellular therapy and clinical haematology department

Lille CHRU Hospital, Internal medicine and clinical immunology department

La Timone Hospital, Dermatology and cutaneous oncology department

Lapeyronie Hospital, Rheumatology and Immunology department

La Pitié-Salpêtrière Hospital, Internal medicine and clinical immunology department

Cochin Hospital, Rheumatology department

Necker Hospital, Adult haematology department

Strasbourg Hospital, Rheumatology department

Toulouse Hospital, Dermatology department

Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis

Dual energy x-ray absorptiometry at lumbar spine (L2-L4)

Dual energy x-ray absorptiometry at left femoral neck and total left hip

Biological assessment: complete blood count, creatinemia, electrolytes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, c-reactive protein (CRP), phosphocalcic analyses with calcemia, phosphoremia, parathormone, vitamin D (25-OH-D), β-Human Chorionic Gonadotropin (HCG) (if needed)
Clinical assessment: blood pressure, pulse, weight, height, PS, temperature

Dual energy x-ray absorptiometry at lumbar spine (L2-L4), left femoral neck and total left hip

Assistance Publique - Hôpitaux de Paris

CEREMAST

Each tablet will contain 27 mg of 98% pure genistein + 500mg Calcium + 200 IU Vit. D3. Subjects will receive 2 tablets per day 6 days/week for all the duration of the study.
Once a week subjects will receive a tablet containing only 500mg Calcium + 200 IU Vit. D3.

Each tablet will contain 500mg Calcium + 200 IU Vit. D3. Subjects will receive 2 tablets per day 6 days/week for all the duration of the study.
Once a week subjects will take one tablet containing 70mg alendronate.

Osteoporosis, Steroid Induced

Only female XX patients will be included, to avoid interactions with other steroid drugs.

Genistein aglycone

Alendronate Oral Tablet

500mg Calcium + 200 IU Vitamin D3 bid in tablets

Calcium + vitamin D3 tablet

University of Messina

University Hospital

Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

Metabolic, Endocrine, and Central Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

BMD of lumbar spine and femoral will be measured by DEXA (dual energy x-ray absorptiometry)

Xrays of the lumbar spine (T4-L4) will be taken to evaluate the presence of fractures

pQCT (peripheral quantitative computed tomography) will be used for bone quality evaluation

bone turnover markers will be evaluated on peripheral blood

Markers of cardiovascular risk will be evaluated on peripheral blood

Glycaemia and blood lipids will be evaluated on peripheral blood

European Quality of Life Questionnaire will be administered to subjects

skin elasticity will be tested in subjects taking glucocorticoids

markers of thyroid function will be evaluated on peripheral blood

markers of inflammation will be evaluated on peripheral blood

Estrogen receptor polymorphisms will be evaluated on white blood cells

Francesco Squadrito

Full Professor of Pharmacology

Ministry of Health, Italy

Drugs will be labelled as "A" and "B" and so will be the groups. Patients and doctors involved will not be aware of the treatment.

AIH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol will be repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. Total time: 4 weeks. After this AIH protocol, patients will received body weight-assisted treadmill training (BWSTT) for 45 minutes.

Sham protocol: it consists of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. Total time: 4 weeks.After this AIH protocol, patients will received body weight-assisted treadmill training (BWSTT) for 45 minutes.

IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.

Intermittent Hypoxia Arm

Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance.

Normoxia Arm

Total

Sex: Female, Male

Region of Enrollment

The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10m.

Gait Speed With 10-Meter Walk Test

The 6-Minute Walk Test measures the distance (in meters) a patient is able to walk over 6 minutes.

IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.
BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH.

Gait Endurance With the 6-Minute Walk Test

The timed up and go test measures the time (in seconds) it takes the patient to stand-up from a seated position in a chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down.

Gait Speed With the Timed up and go Test

The Ashworth Scale assess muscle tone. It is a 5-points scale ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension).

Percentage of Subjects With Worsening Muscle Tone on the Ashworth Scale

The visual analog test assess general pain intensity. It is a 10-score scale ranging from no pain (score 0) to unbearable pain (score 10).

Percentage of Subjects With Worsening Pain Perception on the "The Visual Analog Test"

The ROCF is a neuropsychological instrument used for assessment of episodic visual memory.
Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.
Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation

Learning and Memory With the Rey-Osterrieth Complex Figure (ROCF) Test

The TAVEC is the Spanish version of the California Verbal Learning Test and is used for the assessment of episodic verbal memory.
Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.
Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation

Learning and Memory With the Complutense Verbal Learning Test (TAVEC)

Acute Intermittent Hypoxia Arm

Overall Study

Dr. Angela Navarrete-Opazo

Spinal Cord Injuries

Patients will breath 9% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.

Acute Intermittent Hypoxia

Patient´s gait will be trained through a weight-assisted treadmill (BWSTT). All recruited patients will start BWSTT at a speed of 0.6 km/hr. The physical therapist will manually correct posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training will be done immediately after the protocol of AIH or Sham and it will last 45 minutes.

Body weight-assisted treadmill training

It consists of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. Total time: 4 weeks.

Sham Protocol

Hospital Mutual de Seguridad

Instituto de Rehabilitación Infantil Teletón

Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients

Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training: a Potential Therapy for Incomplete Spinal Cord Injury Patients

Angela A Navarrete-Opazo, MD, PhD

Angela A Navarrete-Opazo MD, PhD

Sociedad Pro Ayuda del Niño Lisiado

Hospital Clinico Mutual de Seguridad

We enrolled 80 patients of the age 18-80 years suffering from chronic musculo-skeletal pain (low back pain, fibromyalgia, chronic widespread pain) at least 6 months. The 40 patients will receive daily doses of 4000 units of vitamin D for 6 weeks

Vitamin D Deficiency

Chronic Pain Syndrome

Inflammatory Response

vitamin D

Meir Medical Center

The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain

On the day of recruitment blood will be drawn in order to determine the levels of 25 OH-Vitamin D, CRP, IL-6, IL-8, TNF and prostaglandin E2. Vitamin D or placebo will be taken for 6 weeks on top of the individual's daily medications. A second blood analysis will be conducted following the 6 week duration

osteoporosis/tyrosine

Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis

Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

Acute Intermittent Hypoxia and Body Weight Supported Treadmill Training for Incomplete Spinal Cord Injury Patients

The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain

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