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Osteoporosis clinical trials

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NCT ID: NCT01374412 Active, not recruiting - Multiple Myeloma Clinical Trials

Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging

Start date: July 2010
Phase:
Study type: Observational

Subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and localized microcirculation in test animals with osteoporosis, fractures and after placement of bone substitute material with volume computed tomography (VCT) (animals only) and functional magnetic resonance imaging (MRI). In vivo imaging by means of functional MRI and VCT is carried out in osteoporotic rats, both after the induction of fracture as well as after the placement of bone substitute material. Furthermore, patients with asymptomatic MM are investigated with functional MR-Imaging (Dynamic Contrast Enhancement- MRI and Intravoxel incoherent motion (IVIM)-imaging) longitudinally to predict the occurrence of osteolysis and the time to progression regarding SLIM-CRAB-Criteria (Rajkumar et al., Lancet Oncology, 2014). Hypothesis: 1. Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI 2. Functional MRI has prognostic value regarding occurrence of osteolysis and progression to MM regarding SLIM-CRAB-Criteria

NCT ID: NCT01370941 Completed - Osteoporosis Clinical Trials

The Effect of Chymosin on the Intestinal Absorption of Calcium

Chymosin
Start date: April 2011
Phase: Phase 1
Study type: Interventional

An adequate calcium intake is important for bone turnover and the risk of developing osteoporosis. Yet many studies have documented that supplementation with calcium tablets are often associated with a poor compliance, therefore it is important to explore ways to better calcium influx. Calcium consumed through dairy products must first be cleaved from the molecules which it is bound to before it can be absorbed. Chymosin is an enzyme which cleaves the protein binding between some amino acids in κ-casein. The reaction occurs after ingestion of milk and causes a process whereby the time the milk is staying gastrointestinal tract is extended, this can lead to enhanced uptake of calcium. When the body's calcium balance is in equilibrium excretion in urine (24 h) in roughly the size of the intake, whereby a measurement of circadian urine excretion of calcium can determine the amount of calcium absorbed from the intestine. The investigators want to clarify whether the addition of chymosin to milk increases calcium absorption. Secondary to explore issues of significance for this effect, including vitamin D status and amount of daily calcium intake and whether a change in calcium absorption has immediate effects on bone turnover (measured as plasma osteocalcin, bone specific alkaline phosphatase (BSAP), and the renal excretion of cross-linked N-terminal telopeptide of type 1 collagen (NTx/Cr) ratio) and on the parathyroid function (measured as PTH). Finally we will explore relations between bone mineral density (BMD) and the measured parameters (in terms of P-PTH, P-25OHD, P-1,25(OH)2D, P-osteocalcin, P-BSAP, and U-NTx/Cr).

NCT ID: NCT01367730 Completed - Osteoporosis Clinical Trials

Assessment of Bone Micro-Architecture Using HR-pQCT

Start date: April 2012
Phase: N/A
Study type: Observational

In the context of male osteoporosis, we hypothesize that regional changes in trabecular bone, as well as changes in cortical porosity will play a major role, and thus also affect bone strength. In developing therapeutics the response of individual compartments, regional variations post-therapy will have considerable impact on selecting the therapies as well as monitoring response to therapy. This study, a precursor to other therapeutic trials, will lay the ground-work for the future.

NCT ID: NCT01367041 Completed - Osteoporosis Clinical Trials

Effect of Bone on Vibration-Induced Muscle Electrical Activity

PMO-WBV-sEMG
Start date: April 2011
Phase: N/A
Study type: Interventional

The aim of this study is to investigate effects of femur exposed to vibration on the rest muscle electrical activity of hip adductors in cases with postmenopausal osteoporosis. Among patients who will be admitted to the investigators clinic for out-patients and whose bone densitometric measurement will be made with a prediagnosis postmenopausal osteoporosis, a total of 80 voluntaries [40 having postmenopausal osteoporosis (femur neck or total hip T score < -2.0) and 40 Controls (Hip and lumbar bone mineral density normal)] are planned to include in this study. After the left hip bone mineral density (BMD) and BMC is measured in all cases, whole body vibration will be applied in PMO groups and Controls. The rest muscle electrical activity of left hip muscles will be evaluated at pre-treatment, post-treatment and, during treatment in patients with PMO and then their data will be compared with Controls data. Plasma sclerostin level will be measured before and 10th minute after vibration. Cases will stand on vibration plate. WBV will be applied at a frequency of 40 Hz and amplitude of 2 mm for 30 + 30 seconds. WBV will be applied one session only. The left hip BMD and BMC will be evaluated by bone densitometer (Norland). The rest muscle electrical activity of hip adductor muscles at rest will be measured by PowerLab (data acquisition system, ADInstruments, Australia) device. This project is planed to be completed in 3 months.

NCT ID: NCT01360424 Completed - Osteoporosis Clinical Trials

Teriparatide Treatment in Patients With Inherited Osteoporosis

Start date: May 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.

NCT ID: NCT01360099 Completed - Osteoporosis Clinical Trials

Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study

Start date: May 4, 2011
Phase: N/A
Study type: Observational

Background: - Osteoporosis is a condition where the bone becomes more brittle and more likely to break as a person ages. The drugs that people take to treat this condition have prevented many common hip fractures. But these drugs may be associated with problems in the shape and structure of the hip bone after many years of use. These changes in the hip bone may lead to an unusual kind of hip fracture. These fractures are very rare, so it is hard to study them. Researchers want to learn more about these fractures. Objectives: - To compare hip x-rays of three groups: people who have been taking osteoporosis drugs for several years, those who have just started taking them, and those who have never taken these drugs. Eligibility: - People at least 50 years of age who have been taking osteoporosis drugs for at least 5 years. - People at least 50 years of age who have been taking these drugs for less than 1 year. - People at least 50 years of age who have never taken these drugs. Design: - All participants will have three total visits over 3 years. - At the first visit, those taking part will have a medical history and physical exam. They will complete a questionnaire about medication use and bone health. They will also have an x-ray of the hips and pelvis, and have a bone density scan (the kind used to test for osteoporosis) of the hips. Those in the study will repeat these exams and medical history questions at followup visits. These visits will take place 18 months and 36 months after the first study visit. - At any of these visits, participants who may have a hip fracture that does not show up on the x-rays will have an imaging study to examine the bone more closely. - Participants who receive a hip replacement or suffer from a broken bone at any time should inform the study researchers as soon as possible.

NCT ID: NCT01357278 Completed - Osteoporosis Clinical Trials

Active Rehabilitation in Osteoporotic Patients

ARO
Start date: January 2007
Phase: N/A
Study type: Interventional

The main objective of this study is to target risk factors for falling, such as improved quadriceps muscle strength,balance and bone mineral density (BMD), to reduce the risk of osteoporotic fractures. Furthermore, to improve quality of life for patients with osteoporosis through an active rehabilitation program. Sub-goals: 1. To assess the effect of active rehabilitation on risk factors for osteoporotic fractures (muscle strength, bone mineral density, balance and frequency of falling) in women with low bone mineral density (BMD)(t-score<1.5) and radius fracture? 2. To assess how active rehabilitation affect the quality of life of women with low bone mineral density(BMD) (t-score<1.5) and radius fracture?

NCT ID: NCT01350934 Completed - Clinical trials for Osteoporosis, Postmenopausal

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Start date: June 19, 2011
Phase: Phase 4
Study type: Interventional

This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.

NCT ID: NCT01348243 Completed - Clinical trials for Postmenopausal Osteoporosis

Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis

Start date: October 2011
Phase: Phase 3
Study type: Interventional

Clodronic acid 100 mg/3,3 ml is used to prevent and treat postmenopausal osteoporosis. The intramuscular formulation, which is given at a dose of 100 mg every 7 o 14 days, is at least as effective as daily oral therapy and appears more effective than intermittent intravenous treatment. Intramuscular clodronic acid in particular has also been associated with improvements in back pain. The drug is well tolerated, with no deleterious effects on bone mineralization, and use of parenteral therapy eliminates the risk of gastrointestinal adverse effects that may be seen in patients receiving oral bisphosphonates therapy. In order to simplify the therapeutic dosing regimen, reducing the number of administrations per month, and therefore increase adherence to bisphosphonates therapy of the patient, a new formulation of disodium clodronic acid containing 200 mg/4 mL for i.m. administration has been developed. Lidocaine in this new formulation, as local anaesthetic, is maintained at the same concentration as in the 100 mg clodronic acid formulation. The pharmacokinetics and tolerability of the intramuscular formulation of clodronic acid 200 mg in comparison to the marketed formulation clodronic acid 100 mg was evaluated in healthy post-menopausal volunteers. Two formulations were similar in terms of amount and rate of clodronic acid urinary excretion and in terms of safety profile.

NCT ID: NCT01343004 Completed - Osteoporosis Clinical Trials

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

ACTIVE
Start date: April 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.