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Acromegaly clinical trials

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NCT ID: NCT01809808 Active, not recruiting - Acromegaly Clinical Trials

A Prospective Study of Outcome After Therapy for Acromegaly

Start date: September 2003
Phase:
Study type: Observational

The purpose of this study is to evaluate hormone values and other markers of disease activity in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after surgical or other treatment. This study is designed to determine blood levels of growth hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of the disease at diagnosis and how these parameters change over time after surgical or other therapy. The investigators will also obtain hormonal data in a group of 50 healthy subjects who will each be studied just once with an oral glucose tolerance test (OGTT). These data will provide a comparison group to the acromegaly subjects.

NCT ID: NCT01794793 Completed - Prostate Cancer Clinical Trials

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

Start date: June 10, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

NCT ID: NCT01752621 Active, not recruiting - Acromegaly Clinical Trials

Epidemiology of Acromegaly in Denmark 1991-2010

Start date: February 2013
Phase: N/A
Study type: Observational

Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.

NCT ID: NCT01732406 Completed - Acromegaly Clinical Trials

Acromegaly Treatment Quality of Life Study

Start date: January 2013
Phase:
Study type: Observational

The investigators hypothesize that treatment of acromegaly will be associated with an improvement in quality of life compared to active acromegaly. At the same time, they will also be studying the effects of different acromegaly treatments on the quality of life.

NCT ID: NCT01723748 Completed - Acromegaly Clinical Trials

Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

Start date: December 2012
Phase: N/A
Study type: Interventional

The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with: - Glucose intolerance despite normalized insulin sensitivity - Modified peripheral GH activity in peripheral target organs assessed on molecular endpoints

NCT ID: NCT01673646 Completed - Acromegaly Clinical Trials

Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism

Start date: October 16, 2012
Phase: Phase 2
Study type: Interventional

To evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of pasireotide LAR in Japanese patients with active acromegaly or pituitary gigantism. Primary objective was to assess the total-group efficacy of pasireotide LAR on the reduction of mean GH levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) at 3 months of study treatment.

NCT ID: NCT01618513 Completed - Acromegaly Clinical Trials

Treatment of Acromegaly With Somatostatin Analogs: GH vs. IGF-I as Primary Biochemical Target

Start date: June 2012
Phase: Phase 4
Study type: Interventional

Treatment of acromegaly with somatostatin analogs (SA) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. Evaluation of treatment control is based on monitoring blood levels of growth hormone (GH) and insulin-like growth factor-I (IGF-I). However, evaluation of disease control during SA treatment is not always straightforward. It is usually based on normalization of IGF-I and achievement of a certain GH level. In approximately 40% of patients discordant values of GH and IGF-I levels are seen after treatment with SA, with normalized IGF-I levels, despite elevated GH levels. The mechanism behind this observation is unknown, but it indicates that SA may affect this difference. The primary objective of this study is to investigate if disease control during SA treatment is best achieved by monitoring either GH or IGF-I.

NCT ID: NCT01612624 Recruiting - Acromegaly Clinical Trials

Prospective Study on Changes in Acromegaly

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

Rationale: Acromegaly is the clinical syndrome that results from an excess of growth hormone (GH). Craniofacial and hand disproportions due to soft tissue swelling and new bone formation are highly prevalent in patients with active acromegaly. Besides the cosmetic aspects, these changes can impair the quality of life because of the significant morbidity with respect to oral, maxillofacial and hand pathologies as well as respiratory problems such as sleep apnea and changes in speech. At present it is unclear if these craniofacial and hand disproportions, sleep apnea and speech changes are (partially) reversible after successful treatment. Therefore there is no consensus about the information patients should be given about (partial) recovery of facial and hand disproportions after treatment and how the follow-up with respect to oral, maxillofacial, respiratory and hand pathology should be organized. Facial and hand analysis using a 3D stereophotograph and a 3D fusion model of a 3D stereophotograph and a 3D skull reconstruction via cone beam computed tomography (CT)-scan makes it possible to investigate the craniofacial changes due to acromegaly in all facial dimensions together (dentition, bone and soft tissue) and the relational proportions between these facial structures. 3D stereophotography can do the same for the soft tissues of the hand. Combined with disease specific and general quality of life (QOL) questionnaires, a correlation between quality of life and craniofacial and hand disproportions can be determined. Combined with sleep- and speech analysis, a correlation between sleep apnea, speech and craniofacial disproportions can be determined. Primary objective: To investigate the changes in facial- and hand analysis in patients with acromegaly as a result of medical treatment and pituitary surgery, and to investigate the changes in relational proportions between facial- and hand structures, incidence and severity of sleep apnea, incidence and severity of speech changes and QOL. Study design: a prospective case-control study. Study population: Approximately thirty patients newly diagnosed with acromegaly . The results of facial and hand analysis, sleep apnea research and speech analysis of the patient group in different phases of the disease will be compared to the results of a healthy control group. Main study parameters/endpoints: Parameters of facial analysis with 3D stereophotography and cone beam CT and hand analysis with 3D stereophotography , biochemical parameters of disease activity, disease related QOL assessed by 2 validated QOL questionnaires (,the AcroQol and RAND-36 ), speech analysis, the results of the voice handicap index questionnaire and severity of sleep apnea assessed by complete overnight polysomnography and the Epworth sleepiness scale questionnaire. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As a result of participating in this study, subjects have to undergo a cone beam CT. The cone beam CT is associated with exposure to X-ray radiation of 0.069-0.135mSv. This is the same amount of radiation as the amount of background radiation that each person receives in 7 days time during daily life. No adverse effects are expected from this amount of exposure. The investigations will take 10-70 minutes adjacent to every regular outpatient clinic visit. In addition , for polysomnography, subjects will be investigated overnight one or three times in 2,5 years, depending on the results of the first screening polysomnography. Assessment of changes in body appearance, sleep disturbances, speech changes and QOL in a prospective longitudinal fashion will increase the knowledge of the impact of the disease on patient perception of well-being and functioning and will help us refine the treatment goals in patients with acromegaly

NCT ID: NCT01568359 Completed - Acromegaly Clinical Trials

Calcium Homeostasis in Acromegaly: Effect of Surgical/Medical Treatment and Comparison With Nonfunctioning Pituitary Tumors

Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of the study is to evaluate the Calcium homeostasis in adult patients with uncontrolled acromegaly. The measurements will be repeated 3-6 months after the treatment of acromegaly (surgical or medical). The control group consists of patients with nonfunctioning pituitary tumors who will undergo surgical removal.

NCT ID: NCT01538966 Terminated - Acromegaly Clinical Trials

Acromegaly Combination Treatment Study

Start date: March 29, 2012
Phase: N/A
Study type: Interventional

In this study the investigators will evaluate whether combination low dose somatostatin receptor ligand (SRL) and weekly or daily pegvisomant will attain equivalent control of serum insulin-like growth factor (IGF)-1 levels at a lower cost, compared to combination high dose SRL and weekly pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.