Clinical Trials

California Institute of Regenerative Medicine (CIRM)

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate (LLP2A-Ale) in Adult Men and Women with Osteopenia Secondary to Glucocorticoids

UC Davis researchers are looking for patients with Osteopenia..

The purpose of this research study is to evaluate the safety and tolerability of intravenous LLP2A-Ale.

 Eligibility Criteria:

  1. Have Osteopenia
  2. 20-75 years of age
  3. Currently taking prednisone or another Glucocorticoid
  4. Not taking any of the following prohibited medications: bisphosphonate (oral or IV), methotrexate (up to 25 mg/week is allowed), and/or immunosuppressive drugs including rituximab, ofatumumab, ocrelizumab, or alemtuzumab
  5. Able to travel to and attend all study visits

Treatment Protocol:

Subject will be assigned to either the single ascending dose (SAD) group or the multiple ascending dose (MAD) group, and subsequently randomized into one of two treatment groups to receive the active LLP2A-Ale or the placebo.

If selected to participate in the study, subjects will receive a modest compensation for time and travel.

Length of Study: For subjects in the SAD group, the study will be up to 5 months. For subjects in the MAD group, it will be up to 7 months.

 

Pfizer A4091058

A Phase 3 Randomized, Double-Blind, Active-Controlled, Multicenter Study of the Long-Term Safety and Efficacy of Subcutaneous Administration of Tanezumab in Subjects with Osteoarthritis of the Hip or Knee

 UC Davis researchers are looking for patients with Osteoarthritis (OA) of the hips or knees.

 The purpose of this research study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti-inflammatory drugs (NSAIDs) in subjects with OA of the hips or knees.

 Eligibility Criteria:

1.    Have OA in at least one hip or knee

2.    18 years of age or older

3.    Currently taking the following NSAIDs: naproxen, celecoxib, or diclofenac

 Treatment Protocol:

Subject will be randomly assigned to receive active NSAID plus placebo tanezumab or placebo NSAID plus active tanezumab (2.5mg) or placebo NSAID plus active tanezumab (5 mg).

 If selected to participate in the study, subjects will receive a modest compensation for time and travel.

 Length of Study: 21 months

  

Bisphosphonate Drug Holiday Study

A multi-center observational study using biochemical markers of bone turnover to monitor the effects of a bisphosphonate drug holiday

Bisphosphonates such as alendronate (Fosamax) and risedronate (Actonel) are widely used in the prevention and treatment of osteoporosis in postmenopausal women and older men. Recently there has been concern about the risk of adverse events after several years of using these agents.  For some patients, a holiday from bisphosphonates might be considered after 4-5 years of continuous use.

The purpose of this study is to use blood tests of biochemical markers of bone turnover (proteins that are released into the blood during bone formation or bone breakdown) to establish when patients who are on a bisphosphonate drug holiday may begin to lose bone mass again.

Eligibility Criteria:
You may qualify to participate in this study if you are:

•    A postmenopausal woman or man > 50 years old

•    Willing to complete up to 10 study visits at the UC Davis Medical Center. (Visits will be approximately 2 hours each)

•    Have taken oral alendronate (Fosamax) or risedronate (Actonel) for five or more years, and if your doctor is agreeable to starting a drug holiday from this medication

Treatment Protocol:
Subjects going on a bisphosphonate drug holiday will be monitored over a 2 year period. Subjects will provide a blood sample every 3 months. Bone density (via DXA scans) will be measured at baseline, 12 months and 24 months.

If accepted into the study, you will receive study related medical exams, lab tests and DXA scans and a modest compensation for time and travel.

Length of study: 2 years

 

 

 

To learn about how to participate in a clinical trial, please contact us at:

UC Davis Center for Musculoskeletal Health
4625 2nd Ave., Suite 2000
Sacramento CA 95817

Telephone: 916-734-3011
Fax: 916-734-0901
Facebook: Center for Musculokeletal Health UC Davis Medical Center
Email: CMHClinicalTrials@ucdavis.edu

 

 

 

AbbVie M14-171

A Phase 2a, Multicenter, Randomize, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects with Erosive Hand Osteoarthritis

The purpose of this study is to evaluate the effectiveness of the drug ABT-981 in decreasing pain and inflammation in patients with erosive hand OA.

ABT-981 is a new type of antibody that blocks two different proteins, IL-1α and IL-1β, which play a major role in the development and progression of Osteoarthritis (OA). ABT-981 has been studied in healthy volunteers, as well as in subjects with OA of the hand.

 

AbbVie M13-741

A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis

The purpose of this study is to assess the effectiveness of the drug ABT-981 in decreasing pain and inflammation in patients with OA of the knee.

ABT-981 is a new type of antibody that blocks two different proteins, IL-1α and IL-1β, which play a major role in the development and progression of Osteoarthritis (OA). ABT-981 has been studied in healthy volunteers, as well as in subjects with OA of the knee.

 

Myoscience

A Multi-Center, Prospective, Double-Blind, Randomized Controlled Study to Evaluate the Effectiveness and Safety of the iovera‚ó¶ Device for the Temporary Relief of Pain Associated with Knee Osteoarthritis

The purpose of this study is to evaluate the effectiveness of a cold therapy device for the temporary reduction of pain associated with knee OA. The cryotherapy targets nerve tissue, providing pain relief for up to 180 days.

 

Amgen 162

A Phase 3 Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

The purpose of this study is to find out if a drug called denosumab is safe and effective in people who have osteoporosis or are at risk of developing osteoporosis as a result of taking glucocorticoids. The primary objective of this trial is to evaluate the effectiveness and safety of an FDA approved drug, denosumab, compared to another FDA approved drug, risedronate.

Denosumab is a fully human monoclonal antibody designed to target a protein that acts as the primary signal for bone removal and overwhelms the body’s natural defenses against bone destruction, whereas risedronate is a bisphosphonate that strengthens bone by inhibiting bone removal by osteoclast.

 

Orthotrophix 100

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects with Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees

The purpose of the study is to learn more about the drug TPX-100, a synthetic peptide derived from human protein believed to stimulate precursor cells to form hyaline cartilage.  TPX-100 represents a first-in-class and first-in-indication, disease-modifying agent administered via injection to the knee.

TPX-100 has been shown to stimulate tissue-appropriate regeneration of dentin (a calcified tissue of the body), bone, and cartilage. Successful clinical development of TPX-100 can be expected to significantly reduce the disability associated with knee OA and create a treatment option to be considered before, or instead of, surgery.


Amgen 785

A Phase 3 Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

The purpose of the study is to learn more about the drug Romosozumab in women with postmenopausal osteoporosis.  This study will see if Romosozumab prevents fractures of the bone and whether it causes any side effects.

Romosozumab is a monoclonal antibody delivered via injection that is designed to increase bone formation by inhibiting a protein associated with bone loss.

You will also be provided with calcium and vitamin D supplements for the duration of the study.

 

Teva 45070

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients with Primary Osteoarthritis Affecting a Single Knee

The purpose of the study is to learn more about the effectiveness of the drug TV-45070 in reducing knee pain in subjects with Osteoarthritis (OA) of the knee. TV45070 is an ointment belonging to the drug class known as sodium channel blockers which interferes with the transmission of pain impulses in the nerves.

Xoma

A Phase 2 Proof-of-concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

The primary objective of this trial is to find out more about a clinical trial drug called Gevokizumab.

Gevokizumab is a monoclonal antibody meant to limit the action of specific proteins in body that release and cause inflammation.

The purpose of this study is to determine what side effects the drug may cause, and whether the drug is useful to treat and help relieve the signs and symptoms of Erosive Osteo-Arthritis of the Hand.

Knee Osteoarthritis Tanezumab

The primary objective of this trial was to evaluate the effectiveness and safety of an investigational new drug called Tanezumab and whether it helps relieve the signs and symptoms of knee osteoarthritis.  Tanezumab is an antibody.  An antibody is a type of protein that is produced by the immune system to help protect the body against foreign compounds.  Tanezumab acts against another protein, called human nerve growth factor (NGF).  NGF is a natural compound that’s made by the body and is involved in causing a person to feel pain.  It is thought that the binding of tanezumab to NGF can block NGF activity, reducing the subject’s pain.

http://www.ucdmc.ucdavis.edu/publish/news/newsroom/4365