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112 active trials for Osteoporosis

Exploring Efficacy, Cost Effectiveness and Experiences Related to Adherence of Different Bisphosphonate Regimens for the Prevention of Osteoporotic Fragility Fractures.

Osteoporosis is a condition where bones become weak and fragile and can easily break. Suffering from one fragility fracture doubles your chance of having another. These fractures can affect a person's life significantly and contribute to significant costs to the UK (United Kingdom) health service. Bisphosphonates are used to treat osteoporosis and help prevent fractures. The most commonly used bisphosphonate treatment is Alendronate, but taking it correctly is complicated and side-effects are common. Therefore only 1 in 4 people continue with Alendronate beyond 2 years. There are different forms of bisphosphonates that can be given in different ways and frequencies and may be more acceptable and tolerated by patients. The study will look at how effective different bisphosphonate regimens are compared to Alendronate at preventing fractures, whether the reduction in fracture risk can be achieved at reasonable financial cost and establish acceptability of different approaches to patients. The study will be completed in 2 stages, Stage 1A and Stage 1B in parallel, followed by Stage 2. Stage 1A will update a systematic review to inform which regimens are most effective at reducing fractures and provide the best value for money. Stage 1B will consist of qualitative, semi-structured interviews from a sample of stakeholders in receipt of or involved in the delivery of different bisphosphonate regimens, in order to identify which bisphosphonate regimens are most acceptable to patients and the barriers to effective compliance and adherence. Stage 2 will use focus groups and workshops with stakeholders and commissioners to discuss uncertainties from Stage 1 and identify the most important outstanding questions for future research.

Start: March 2020

Bone Health in Youth With Type 1 Diabetes

This is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.

Start: August 2013

Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis

Teriparatide (PTH) is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk, it does not give information on bone structure (called bone geometry) which can also tell us a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip, while BMD at the forearm may decrease after 20 months of therapy. However, bone biopsies of the pelvis done on people taking teriparatide show improvement of bone geometry (ie bone thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist may be occurring as well. Currently, there is a new technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected both by BMD and bone structure (as well as other material properties), our group is interested in examining changes in bone geometry at the radius and tibia in men and women with osteoporosis who receives 24 months of teriparatide therapy. The investigators believe that this new approach of measuring bone strength will help us better understand the mechanisms of therapeutic efficacy of teriparatide. In addition, measuring indices of bone strength such as the material composition (bone mineral content or BMD) and structural properties of bone (size and shape, and microarchitecture) may provide more data about the mechanisms of how teriparatide treatment can decrease fracture risk. In the end, this data will benefit and improve patient care by allowing us to show patients and their providers that whether BMD increases, decreases or stay the same, there are changes in their bone geometric structure with teriparatide therapy that increases bone strength.

Start: November 2004

Teriparatide (PTH) and Bone Strength in Postmenopausal Women

This study will investigate the effects on bone quality of a medication (Teriparatide) used to treat people with severe osteoporosis. Teriparatide is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk, it does not give information on bone structure (called bone geometry) which can also tell us a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip, while BMD at the forearm decreases after 20 months of therapy. Whether this decrease of BMD at the forearm suggests a higher risk of wrist fracture or a change in bone structure is unclear. Bone biopsies of the pelvis done on people taking teriparatide shows improvement of bone geometry (ie bone thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist may be occurring as well. Currently, there is a new technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected both by BMD and bone structure (as well as other material properties), our group is interested in examining changes in bone geometry at the forearm (a non-weight bearing site) and ankle (a weight bearing site) in postmenopausal women with osteoporosis who receive 24 months of teriparatide therapy. The investigators believe that this new approach of measuring bone strength will help us better understand whether teriparatide has different effects at different bone sites.

Start: June 2008

Effects of Lagenbone on Bone Mineral Density

To study the effects of the herbal supplement Lagenbone on Bone Mineral Density

Start: July 2019

Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

A 12 month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.

Start: March 2018

Osteoporosis and Haemophilia

The aim of this study is to evaluate the prevalence of osteoporosis in adult patients with haemophilia.

Start: August 2020

Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

This study evaluates physiological measurements and their role in among falls in healthy elderly (65yr or older) or elderly suffering from osteoporosis. The study further seeks to evaluate if dancing can be used as training for preventing falls.

Start: February 2019

Long-term Follow-up of AGN1 Treated Patients

The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP. To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1). Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.

Start: August 2020

Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years

The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)

Start: July 2013

CT-Based Modeling of Bone Micro-Architecture and Fracture-Risk in COPD

The goal of this translational study is to establish a newly emerging CT-based tool for the characterization of changes in bone micro-architecture and assessment of their implications for fracture-risk in a population of COPD patients at risk for osteoporosis. The tool will be suitable and generalizable across emerging CT scanners from different vendors, and it will provide a more structurally-based assessment of osteoporosis and bone loss than is provided by simple bone density measures. The study will characterize the impact of different COPD-related factors on bone structure, and their implications for fracture-risk, leading to the development of a COPD-specific model for assessment of fracture-risk that will utilize patient-specific demographic, clinical and radiographic data, and CT BMD at the spine, as well as bone structural measures at the hip and/or ankle.

Start: February 2019

Efficacy of Oral Ibandronate in Osteoporosis

There has been no comparative data between oral ibandronate and oral ibandronate plus active vitamin D

Start: October 2017

Efficacy of Zoledronic Acid in Osteoporosis

There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.

Start: October 2017

Changes of Bone Turnover Markers and Bone Mineral Density After Osteoporosis Treatment

To examine the changes of bone mineral density and bone turnover markers after Bonviva treatment in osteoporotic patients

Start: June 2014

Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients: The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months. The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months. The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.

Start: October 2018

Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients

The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy: SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months

Start: November 2018

The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis

In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.

Start: December 2014

Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients

This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord in improving the quality and quantity of spinal density of osteoporosis patients proven by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate improvement of quality of pain with visual analog scale (VAS).

Start: August 2020

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

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: Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI Functional MRI has prognostic value regarding occurrence of osteolysis and progression to MM regarding SLIM-CRAB-Criteria

Start: July 2010

C-STOP Fracture Trial

The objective of the proposed research is to improve quality of care for older outpatients who present to Emergency Departments and Fracture Clinics with an osteoporosis-related wrist or other upper extremity fracture. Although most of these patients warrant evidence-based and guideline-recommended osteoporosis testing and treatment, numerous studies demonstrate treatment rates less than 10-20% in the year post-fracture. Several trials, including the investigators own prior studies, have tried to address this osteoporosis care-gap and have reported that various multifaceted interventions (combinations of patient and physician education, guidelines, and physician reminders) can modestly improve treatment rates compared with usual care, although 60-70% of the patients exposed to these interventions still remain untreated. The investigators believe that a case-manager (who identifies and independently sees patients in clinic, arranges bone mineral density [BMD] tests, and offers guideline-based treatment to those with low BMD) represents a potential solution that holds great promise. The investigators hypothesize that an osteoporosis case-manager will effectively and efficiently increase rates of osteoporosis treatment in older outpatients with upper extremity fractures when compared with a documented effective and cost-saving multifaceted intervention. To test this hypothesis the investigators propose a pragmatic patient-level randomized controlled comparative effectiveness trial with blinded outcomes ascertainment that compares the case-manager strategy with the multifaceted intervention.

Start: September 2012